HEARTMATE II LVAS, EUROPE

LEFT VENTRICULAR ASSIST DEVICE

This device is manufactured by THORATEC CORP, THORATEC CORPORATION.

The following problems were reported about this device:

Date Event Type Patient Problem Device Problem
2024-01-02 Malfunction Cardiac Arrest Pumping Stopped, Infusion or Flow Problem
2023-12-10 Death Insufficient Information None
2023-06-21 Death Insufficient Information Adverse Event Without Identified Device or Use Problem
2019-09-09 Injury None Pumping Stopped
2019-08-24 Injury None Adverse Event Without Identified Device or Use Problem
2019-08-15 Injury None Adverse Event Without Identified Device or Use Problem
2019-08-03 Injury None Decreased Pump Speed
2019-07-31 Injury None Tear, Rip or Hole in Device Packaging, Material Split, Cut or Torn
2019-07-12 Injury None Break
2019-07-01 Injury None Break
2019-06-25 Injury None Adverse Event Without Identified Device or Use Problem
2019-06-19 Injury None Break, Decreased Pump Speed
2019-06-07 Injury None Adverse Event Without Identified Device or Use Problem
2019-05-13 Injury None Naturally Worn, Material Split, Cut or Torn
2019-05-03 Injury None Break, Pumping Stopped
2019-04-27 Injury None Adverse Event Without Identified Device or Use Problem
2019-04-26 Injury None Decreased Pump Speed
2019-04-25 Injury None Naturally Worn, Adverse Event Without Identified Device or Use Problem, Material Split, Cut or Torn
2019-04-23 Injury None Break, Pumping Stopped
2019-04-21 Death None Break, Pumping Stopped
2019-03-27 Death Insufficient Information Adverse Event Without Identified Device or Use Problem
2019-02-21 Death None Adverse Event Without Identified Device or Use Problem
2019-01-16 Malfunction None Break
2019-01-11 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-08 Injury None Naturally Worn, Material Split, Cut or Torn
2019-01-02 Injury None Break, Decreased Pump Speed
2018-12-29 Death None Adverse Event Without Identified Device or Use Problem
2018-12-21 Death None Adverse Event Without Identified Device or Use Problem
2018-12-18 Injury None Decreased Pump Speed
2018-12-13 Death None Adverse Event Without Identified Device or Use Problem
2018-11-17 Death None Adverse Event Without Identified Device or Use Problem
2018-11-12 Malfunction None Naturally Worn, Material Split, Cut or Torn
2018-10-25 Malfunction None Break
2018-10-24 Malfunction None Naturally Worn, Material Split, Cut or Torn
2018-10-22 Malfunction None Break
2018-10-22 Injury None Infusion or Flow Problem
2018-09-24 Injury None Break, Pumping Stopped, Material Split, Cut or Torn
2018-09-20 Injury None Pumping Stopped, Infusion or Flow Problem
2018-08-26 Death None Use of Device Problem, Complete Loss of Power
2018-08-14 Malfunction None Break, Pumping Stopped
2018-08-13 Injury None Break, Pumping Stopped
2018-07-30 Injury None Break, Pumping Stopped
2018-07-02 Injury None Break, Pumping Stopped
2018-06-26 Death None Adverse Event Without Identified Device or Use Problem
2018-06-26 Injury None Adverse Event Without Identified Device or Use Problem
2018-06-20 Injury None Break, Pumping Stopped
2018-06-18 Injury None Break, Electrical Shorting
2018-05-13 Injury None Naturally Worn, Material Split, Cut or Torn
2018-05-03 Malfunction None Break, Device Stops Intermittently
2018-04-08 Injury None Infusion or Flow Problem
2018-04-03 Injury None Break, Device Stops Intermittently
2018-03-26 Malfunction None Leak/Splash
2018-03-19 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-15 Injury None Break, Decreased Pump Speed
2018-03-14 Death None Adverse Event Without Identified Device or Use Problem
2018-03-13 Injury None High Readings, Infusion or Flow Problem
2018-03-12 Injury None Break, Device Stops Intermittently
2018-03-11 Injury None Pumping Stopped, Device Stops Intermittently
2018-03-09 Injury None Break, Device Stops Intermittently
2018-03-07 Injury None Device Stops Intermittently
2018-03-07 Malfunction None Break, Device Stops Intermittently
2018-03-02 Malfunction None Break, Device Stops Intermittently
2018-02-27 Malfunction None Break, Device Stops Intermittently
2018-02-26 Malfunction None Break, Device Stops Intermittently
2018-02-16 Death None High Readings, Infusion or Flow Problem
2018-02-16 Injury None Break, Device Stops Intermittently
2018-02-05 Death None Adverse Event Without Identified Device or Use Problem
2018-02-01 Death None Break, Device Stops Intermittently
2018-01-31 Death None Adverse Event Without Identified Device or Use Problem
2018-01-26 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-26 Malfunction None Partial Blockage
2018-01-18 Injury None Break, Device Stops Intermittently
2018-01-15 Malfunction None Break, Decreased Pump Speed, Device Stops Intermittently
2018-01-05 Malfunction None Break, Device Stops Intermittently, Noise, Audible
2017-12-25 Malfunction None Infusion or Flow Problem
2017-12-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-18 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-12 Malfunction None Break, Device Stops Intermittently
2017-12-12 Malfunction None Break, Device Stops Intermittently
2017-12-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-03 Malfunction None Break, Device Stops Intermittently
2017-11-30 Malfunction None Device Stops Intermittently, Low Readings
2017-11-25 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-23 Malfunction None Break, Decreased Pump Speed
2017-11-22 Injury None High Readings, Infusion or Flow Problem
2017-11-21 Malfunction None Break, Device Stops Intermittently, Naturally Worn
2017-11-21 Injury None Partial Blockage
2017-11-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-20 Injury None Infusion or Flow Problem
2017-11-16 Death None Break, Device Stops Intermittently
2017-11-15 Malfunction None Decreased Pump Speed, Electrical Shorting
2017-11-13 Malfunction None Device Stops Intermittently
2017-11-12 Injury None Break, Pumping Stopped
2017-11-10 Injury None Partial Blockage, High Readings
2017-11-08 Malfunction None Device Stops Intermittently
2017-11-06 Malfunction None Break, Decreased Pump Speed
2017-10-31 Malfunction None Break, Decreased Pump Speed
2017-10-17 Death None Device Stops Intermittently
2017-10-12 Malfunction None Break, Device Stops Intermittently
2017-10-11 Malfunction None Device Stops Intermittently, Electrical Shorting
2017-10-11 Malfunction None Break
2017-10-10 Injury None Break, Device Stops Intermittently
2017-10-09 Injury None Device Stops Intermittently
2017-10-02 Injury None Break, Device Stops Intermittently
2017-09-30 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-26 Injury None Insufficient Information
2017-09-15 Injury None Break, Device Stops Intermittently, High Readings
2017-09-14 Death None Break, Decreased Pump Speed
2017-09-13 Injury None Break
2017-09-12 Malfunction None Device Stops Intermittently
2017-09-11 Malfunction None Break, Device Stops Intermittently
2017-09-02 Malfunction None Device Stops Intermittently, Electrical Shorting
2017-08-16 Injury None High Readings
2017-08-15 Injury None Pumping Stopped
2017-08-11 Injury None High Readings
2017-08-08 Malfunction None Device Stops Intermittently, Electrical Shorting
2017-08-04 Malfunction None Device Stops Intermittently, Electrical Shorting
2017-07-28 Malfunction None Break, Device Stops Intermittently
2017-07-22 Injury None Device Stops Intermittently, High Readings, Infusion or Flow Problem
2017-07-20 Malfunction None Break, Device Stops Intermittently
2017-07-20 Injury None Partial Blockage, Pumping Stopped
2017-07-18 Death None Insufficient Information
2017-07-14 Injury None Adverse Event Without Identified Device or Use Problem, Insufficient Information
2017-07-08 Malfunction None Device Stops Intermittently, Electrical Shorting
2017-07-04 Death None High Readings, Infusion or Flow Problem
2017-07-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-03 Malfunction None Break, Device Stops Intermittently
2017-06-28 Death None Migration or Expulsion of Device, Infusion or Flow Problem
2017-06-25 Injury None Break, Decreased Pump Speed
2017-06-24 Death None Adverse Event Without Identified Device or Use Problem
2017-06-20 Injury None Break, Device Stops Intermittently
2017-06-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-20 Malfunction None Device Stops Intermittently, Electrical Shorting
2017-06-20 Death None High Readings
2017-06-17 Malfunction None Adverse Event Without Identified Device or Use Problem
2017-06-17 Injury None Break, Decreased Pump Speed, Device Stops Intermittently
2017-06-16 Injury None Partial Blockage
2017-06-07 Death None Low Readings, Insufficient Information
2017-06-05 Injury None Partial Blockage, Infusion or Flow Problem
2017-06-04 Death None Pumping Stopped, Use of Device Problem
2017-05-22 Malfunction None Device Stops Intermittently, Electrical Shorting
2017-05-19 Injury None High Readings, Infusion or Flow Problem
2017-05-16 Malfunction None Break, Device Stops Intermittently
2017-05-16 Injury None Device Stops Intermittently, Electrical Shorting
2017-05-15 Death None Disconnection
2017-05-11 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-08 Malfunction None Device Stops Intermittently, Electrical Shorting
2017-05-04 Malfunction None Break, Device Stops Intermittently
2017-05-03 Injury None Break, Naturally Worn
2017-04-30 Injury None High Readings
2017-04-30 Malfunction None Decreased Pump Speed
2017-04-28 Injury None Low Readings, Infusion or Flow Problem
2017-04-24 Malfunction None Break, Device Stops Intermittently
2017-04-20 Death None Adverse Event Without Identified Device or Use Problem
2017-04-18 Malfunction None Break, Device Stops Intermittently
2017-04-12 Injury None High Readings, Infusion or Flow Problem
2017-04-04 Malfunction None Decreased Pump Speed, Device Stops Intermittently, Electrical Shorting
2017-04-03 Death None Adverse Event Without Identified Device or Use Problem
2017-03-31 Death None Adverse Event Without Identified Device or Use Problem
2017-03-30 Malfunction None Decreased Pump Speed, Device Stops Intermittently
2017-03-30 Malfunction None Adverse Event Without Identified Device or Use Problem
2017-03-27 Injury None High Readings
2017-03-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-14 Injury None Break, Device Stops Intermittently
2017-03-14 Injury None Partial Blockage, High Readings
2017-03-14 Injury None Partial Blockage, High Readings, Infusion or Flow Problem
2017-03-10 Injury None Device Stops Intermittently, Electrical Shorting
2017-03-09 Death None Adverse Event Without Identified Device or Use Problem
2017-02-28 Death None Insufficient Information
2017-02-27 Malfunction None Device Stops Intermittently, Electrical Shorting
2017-02-24 Injury None Device Stops Intermittently
2017-02-15 Malfunction None Decreased Pump Speed
2017-02-13 Injury None Device Stops Intermittently, Electrical Shorting
2017-02-13 Injury None Break, Decreased Pump Speed
2017-02-09 Death None No Display/Image
2017-02-06 Death None Break, Device Stops Intermittently, High Readings
2017-02-04 Injury None Device Stops Intermittently, Power Problem
2017-02-04 Injury None Device Stops Intermittently, Electrical Shorting
2017-02-03 Injury None High Readings, Infusion or Flow Problem
2017-02-01 Death None High Readings, Infusion or Flow Problem
2017-01-25 Injury None Partial Blockage
2017-01-24 Injury None Decreased Pump Speed, Device Stops Intermittently
2017-01-19 Death None Adverse Event Without Identified Device or Use Problem
2017-01-16 Injury None High Readings
2017-01-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-11 Injury None Device Stops Intermittently
2017-01-09 Injury None Break, Moisture Damage, Device Stops Intermittently
2017-01-01 Injury None High Readings
2016-12-30 Death None Adverse Event Without Identified Device or Use Problem
2016-12-29 Injury None High Readings, Infusion or Flow Problem
2016-12-23 Injury None Infusion or Flow Problem
2016-12-22 Injury None Infusion or Flow Problem
2016-12-20 Injury None Break, Naturally Worn
2016-12-19 Injury None High Readings, Infusion or Flow Problem
2016-12-16 Injury None High Readings, Infusion or Flow Problem
2016-12-14 Malfunction None Device Stops Intermittently, Electrical Shorting
2016-12-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-12 Injury None High Readings, Infusion or Flow Problem
2016-11-29 Injury None Infusion or Flow Problem
2016-11-28 Death None Infusion or Flow Problem
2016-11-25 Injury None High Readings, Infusion or Flow Problem
2016-11-25 Injury None High Readings, Malposition of Device
2016-11-24 Death None Adverse Event Without Identified Device or Use Problem
2016-11-19 Injury None Pumping Stopped
2016-11-17 Injury None Adverse Event Without Identified Device or Use Problem, Noise, Audible
2016-11-15 Injury None Infusion or Flow Problem
2016-11-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-13 Malfunction None Device Stops Intermittently, Electrical Shorting
2016-11-11 Injury None High Readings
2016-10-28 Death None Adverse Event Without Identified Device or Use Problem
2016-10-28 Injury None High Readings, Infusion or Flow Problem
2016-10-28 Injury None Break
2016-10-27 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-26 Malfunction None Device Stops Intermittently
2016-10-25 Malfunction None Break, Decreased Pump Speed
2016-10-24 Injury None Break, Device Stops Intermittently
2016-10-19 Injury None Device Stops Intermittently
2016-10-18 Malfunction None Adverse Event Without Identified Device or Use Problem
2016-10-16 Death None Adverse Event Without Identified Device or Use Problem
2016-10-09 Death None Pumping Stopped, Device Stops Intermittently, Electrical Shorting
2016-10-09 Malfunction None Moisture Damage
2016-10-06 Injury None Infusion or Flow Problem
2016-10-06 Injury None Infusion or Flow Problem
2016-10-02 Death None Adverse Event Without Identified Device or Use Problem
2016-09-30 Injury None Adverse Event Without Identified Device or Use Problem
2016-09-26 Injury None Overheating of Device, High Readings, Infusion or Flow Problem
2016-09-25 Injury None Break, Decreased Pump Speed, Device Stops Intermittently
2016-09-23 Injury None Adverse Event Without Identified Device or Use Problem
2016-09-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-09-19 Injury None High Readings
2016-09-16 Injury None Device Stops Intermittently, Electrical Shorting
2016-09-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-09-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-09-08 Injury None Infusion or Flow Problem
2016-09-06 Injury None Adverse Event Without Identified Device or Use Problem
2016-09-06 Malfunction None Device Stops Intermittently, Stretched
2016-08-22 Injury None Adverse Event Without Identified Device or Use Problem
2016-08-21 Injury None Partial Blockage, Detachment Of Device Component, High Readings, Device Dislodged or Dislocated
2016-08-18 Malfunction None Cut In Material, Adverse Event Without Identified Device or Use Problem
2016-08-12 Injury None High Readings
2016-08-07 Malfunction None Device Stops Intermittently
2016-08-06 Injury None Adverse Event Without Identified Device or Use Problem
2016-08-05 Injury None Break
2016-08-04 Malfunction None Pumping Stopped, High Readings
2016-08-01 Malfunction None Failure to Sense
2016-07-27 Death None Decreased Pump Speed, Pumping Stopped
2016-07-26 Injury None Device Stops Intermittently, Infusion or Flow Problem
2016-07-22 Injury None Partial Blockage
2016-07-21 Injury None High Readings
2016-07-20 Malfunction None Device Stops Intermittently
2016-07-19 Injury None Device Stops Intermittently, Electrical Shorting
2016-07-19 Injury None Decreased Pump Speed, Device Stops Intermittently
2016-07-19 Malfunction None Adverse Event Without Identified Device or Use Problem
2016-07-08 Injury None Adverse Event Without Identified Device or Use Problem
2016-07-07 Death None Adverse Event Without Identified Device or Use Problem
2016-06-28 Malfunction None Device Stops Intermittently, Electrical Shorting
2016-06-28 Malfunction None Pumping Stopped
2016-06-24 Death None Adverse Event Without Identified Device or Use Problem
2016-06-21 Death None Infusion or Flow Problem
2016-06-13 Death None Disconnection
2016-06-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-03-17 Death None Adverse Event Without Identified Device or Use Problem
2016-01-30 Death None Adverse Event Without Identified Device or Use Problem
2016-01-27 Injury None Migration or Expulsion of Device
2015-12-07 Death None Adverse Event Without Identified Device or Use Problem
2015-11-17 Death None Adverse Event Without Identified Device or Use Problem
2015-11-10 Death None Adverse Event Without Identified Device or Use Problem
2015-10-28 Death None Adverse Event Without Identified Device or Use Problem
2015-10-15 Death None Adverse Event Without Identified Device or Use Problem
2015-10-14 Death None Adverse Event Without Identified Device or Use Problem
2015-10-13 Death None Adverse Event Without Identified Device or Use Problem
2015-09-15 Death None Adverse Event Without Identified Device or Use Problem
2015-08-14 Death None Adverse Event Without Identified Device or Use Problem
2015-08-12 Death None Adverse Event Without Identified Device or Use Problem
2015-06-04 Death None Adverse Event Without Identified Device or Use Problem
2015-05-11 Injury None Kinked, Infusion or Flow Problem
2015-05-07 Injury None Decreased Pump Speed
2015-05-01 Injury None Pumping Stopped, Material Torqued
2015-05-01 Injury None Infusion or Flow Problem
2015-04-30 Injury None Adverse Event Without Identified Device or Use Problem
2015-04-29 Injury None High Readings, Infusion or Flow Problem
2015-04-25 Injury None High Readings, Infusion or Flow Problem
2015-04-17 Death None Adverse Event Without Identified Device or Use Problem
2015-04-15 Death None Adverse Event Without Identified Device or Use Problem
2015-04-11 Death None Adverse Event Without Identified Device or Use Problem
2015-04-10 Injury None High Readings, Infusion or Flow Problem
2015-04-01 Injury None Adverse Event Without Identified Device or Use Problem
2015-04-01 Injury None Adverse Event Without Identified Device or Use Problem
2015-03-30 Injury None Infusion or Flow Problem
2015-03-30 Injury None Malposition of Device, Infusion or Flow Problem
2015-03-30 Injury None Adverse Event Without Identified Device or Use Problem
2015-03-28 Malfunction None Decreased Pump Speed, Device Stops Intermittently
2015-03-27 Malfunction None Break, Device Stops Intermittently, Battery Problem
2015-03-26 Injury None Infusion or Flow Problem
2015-03-26 Injury None Pumping Stopped, Material Twisted/Bent
2015-03-24 Injury None Break, Device Stops Intermittently
2015-03-18 Death None Adverse Event Without Identified Device or Use Problem
2015-03-17 Malfunction None Break, Decreased Pump Speed
2015-03-09 Injury None Adverse Event Without Identified Device or Use Problem
2015-03-01 Injury None Adverse Event Without Identified Device or Use Problem
2015-02-11 Death None Adverse Event Without Identified Device or Use Problem
2015-02-10 Death None Adverse Event Without Identified Device or Use Problem
2015-02-02 Malfunction None Device Stops Intermittently
2015-01-25 Death None Adverse Event Without Identified Device or Use Problem
2015-01-15 Injury None Device Damaged by Another Device, Material Deformation
2015-01-15 Malfunction None Adverse Event Without Identified Device or Use Problem
2015-01-01 Injury None Infusion or Flow Problem
2014-12-23 Malfunction None Device Stops Intermittently
2014-11-18 Death None Adverse Event Without Identified Device or Use Problem
2014-11-02 Malfunction None Partial Blockage
2014-10-24 Death None Adverse Event Without Identified Device or Use Problem
2014-09-19 Death None Adverse Event Without Identified Device or Use Problem
2014-09-07 Death None Adverse Event Without Identified Device or Use Problem
2014-09-07 Death None Adverse Event Without Identified Device or Use Problem
2014-09-01 Injury None Adverse Event Without Identified Device or Use Problem
2014-07-19 Death None Adverse Event Without Identified Device or Use Problem
2014-06-24 Injury None Cut In Material
2014-06-14 Death None Adverse Event Without Identified Device or Use Problem
2014-06-12 Injury None Adverse Event Without Identified Device or Use Problem
2014-06-08 Injury None Infusion or Flow Problem
2014-05-21 Injury None Break, Decreased Pump Speed
2014-05-05 Malfunction None Device Stops Intermittently, Infusion or Flow Problem
2014-05-03 Injury None High Readings, Infusion or Flow Problem
2014-04-29 Injury None Infusion or Flow Problem
2014-04-22 Death None Adverse Event Without Identified Device or Use Problem
2014-04-16 Malfunction None Decreased Pump Speed, Device Stops Intermittently, Infusion or Flow Problem
2014-04-14 Injury None Break, Infusion or Flow Problem
2014-04-06 Injury None Pumping Stopped
2014-04-01 Malfunction None Decreased Pump Speed
2014-03-31 Death None Adverse Event Without Identified Device or Use Problem
2014-03-31 Death None Break, Decreased Pump Speed
2014-03-29 Death None Adverse Event Without Identified Device or Use Problem
2014-03-24 Injury None Break, Device Stops Intermittently
2014-03-21 Injury None Device Stops Intermittently, Vibration
2014-03-14 Malfunction None Decreased Pump Speed
2014-03-14 Injury None Component Incompatible
2014-03-06 Injury None Other (for use when an appropriate device code cannot be identified)
2014-03-05 Malfunction None Break, Device Stops Intermittently, High Readings
2014-03-03 Injury None High Readings, Infusion or Flow Problem
2014-03-01 Injury None No Audible Alarm, Decreased Pump Speed, Malposition of Device
2014-02-25 Malfunction None Decreased Pump Speed, Device Stops Intermittently, Infusion or Flow Problem
2014-02-25 Injury None Pumping Stopped
2014-02-23 Injury None Pumping Stopped, Infusion or Flow Problem
2014-02-16 Injury None Pumping Stopped, High Readings
2014-02-13 Injury None Adverse Event Without Identified Device or Use Problem
2014-01-30 Injury None Detachment Of Device Component
2014-01-29 Death None Adverse Event Without Identified Device or Use Problem
2014-01-29 Injury None Infusion or Flow Problem
2014-01-27 Injury None Infusion or Flow Problem
2014-01-26 Injury None Infusion or Flow Problem
2014-01-23 Injury None Infusion or Flow Problem
2014-01-20 Malfunction None Break, Decreased Pump Speed
2014-01-17 Injury None Device Stops Intermittently
2014-01-09 Injury None Infusion or Flow Problem
2014-01-05 Death None Adverse Event Without Identified Device or Use Problem
2014-01-03 Injury None Partial Blockage, High Readings, Infusion or Flow Problem
2014-01-02 Death None Adverse Event Without Identified Device or Use Problem
2013-12-31 Death None Infusion or Flow Problem
2013-12-27 Injury None Partial Blockage
2013-12-26 Injury None Adverse Event Without Identified Device or Use Problem
2013-12-25 Injury None High Readings, Infusion or Flow Problem
2013-12-24 Death None Adverse Event Without Identified Device or Use Problem
2013-12-17 Injury None Adverse Event Without Identified Device or Use Problem
2013-12-13 Injury None Infusion or Flow Problem, Insufficient Information
2013-12-10 Death None Other (for use when an appropriate device code cannot be identified), Battery Problem
2013-12-09 Injury None None
2013-12-06 Injury None Other (for use when an appropriate device code cannot be identified)
2013-12-04 Malfunction None Other (for use when an appropriate device code cannot be identified)
2013-12-04 Injury None Other (for use when an appropriate device code cannot be identified)
2013-11-21 Malfunction None None
2013-11-21 Death None None
2013-11-20 Injury None None
2013-11-16 Malfunction None None
2013-11-10 Death None Adverse Event Without Identified Device or Use Problem
2013-11-05 Death None None
2013-11-05 Malfunction None None
2013-11-04 Injury None None
2013-10-30 Death None None
2013-10-24 Injury None None
2013-10-08 Death None Adverse Event Without Identified Device or Use Problem
2013-10-03 Death None Adverse Event Without Identified Device or Use Problem
2013-09-30 Injury None None
2013-09-28 Malfunction None None
2013-09-27 Injury None None
2013-09-20 Injury None None
2013-09-20 Death None None
2013-09-16 Injury None None
2013-09-11 Injury None None
2013-09-09 Injury None None
2013-09-08 Injury None None
2013-09-06 Death None None
2013-09-03 Injury None None
2013-09-01 Injury None None
2013-08-25 Death None None
2013-08-20 Malfunction None None
2013-08-11 Injury None Adverse Event Without Identified Device or Use Problem
2013-08-09 Injury None None
2013-08-08 Malfunction None None
2013-08-05 Malfunction None None
2013-08-04 Injury None None
2013-08-03 Death None None
2013-08-02 Malfunction None None
2013-07-30 Injury None None
2013-07-29 Malfunction None None
2013-07-29 Injury None None
2013-07-16 Malfunction None None
2013-07-16 Death None None
2013-07-15 Malfunction None None
2013-07-15 Injury None None
2013-07-13 Injury None None
2013-07-09 Malfunction None None
2013-07-06 Injury None None
2013-07-04 Injury None None
2013-07-03 Malfunction None None
2013-07-02 Injury None None
2013-06-29 Death None None
2013-06-17 Injury None None
2013-06-13 Malfunction None None
2013-06-12 Injury None None
2013-05-31 Death None None
2013-05-16 Injury None None
2013-05-14 Malfunction None None
2013-05-13 Injury None None
2013-05-10 Injury None None
2013-05-08 Malfunction None None
2013-05-06 Injury None None
2013-04-28 Injury None None
2013-04-19 Injury None None
2013-04-16 Malfunction None None
2013-04-16 Malfunction None None
2013-04-16 Malfunction None None
2013-04-16 Malfunction None None
2013-04-16 Malfunction None None
2013-04-10 Injury None None
2013-04-02 Injury None None
2013-03-28 Injury None None
2013-03-27 Injury None None
2013-03-25 Injury None None
2013-03-24 Injury None None
2013-03-14 Injury None Adverse Event Without Identified Device or Use Problem
2013-02-21 Malfunction None None
2013-02-10 Injury None None
2013-02-07 Death None None
2013-02-06 Injury None None
2013-01-31 Injury None None
2013-01-30 Death None None
2013-01-29 Malfunction None None
2013-01-24 Injury None None
2013-01-19 Injury None None
2013-01-11 Injury None None
2013-01-09 Injury None None
2013-01-07 Injury None None
2013-01-05 Death None None
2012-12-31 Injury None None
2012-12-13 Injury None None
2012-12-07 Injury None None
2012-11-28 Injury None None
2012-11-24 Injury None None
2012-11-21 Injury None None
2012-11-19 Malfunction None None
2012-11-15 Injury None None
2012-11-15 Injury None None
2012-11-14 Injury None None
2012-11-13 Injury None None
2012-11-08 Injury None None
2012-11-05 Injury None None
2012-11-02 Injury None None
2012-10-30 Death None None
2012-10-26 Injury None None
2012-10-21 Death None None
2012-10-18 Malfunction None None
2012-10-16 Injury None None
2012-10-12 Injury None None
2012-10-07 Injury None None
2012-09-24 Injury None None
2012-09-17 Injury None None
2012-09-12 Malfunction None None
2012-09-12 Injury None None
2012-09-09 Injury None None
2012-09-04 Injury None None
2012-08-28 Injury None None
2012-08-28 Injury None None
2012-08-27 Death None None
2012-08-24 Injury None None
2012-08-21 Injury None None
2012-08-20 Injury None None
2012-08-18 Injury None None
2012-08-11 Injury None None
2012-07-30 Injury None None
2012-07-26 Malfunction None None
2012-07-23 Malfunction None None
2012-07-18 Injury None None
2012-07-13 Malfunction None None
2012-07-12 Malfunction None None
2012-07-08 Death None None
2012-06-28 Malfunction None None
2012-06-27 Injury None None
2012-06-24 Injury None None
2012-06-18 Injury None None
2012-05-30 Injury None None
2012-05-29 Injury None None
2012-05-18 Injury None None
2012-05-08 Injury None None
2012-05-06 Death None None
2012-04-25 Injury None None
2012-04-17 Injury None None
2012-04-16 Injury None None
2012-04-14 Injury None None
2012-04-02 Death None None
2012-03-27 Injury None None
2012-03-24 Injury None None
2012-03-21 Malfunction None None
2012-03-21 Malfunction None None
2012-03-21 Malfunction None None
2012-03-21 Malfunction None None
2012-03-21 Malfunction None None
2012-03-21 Malfunction None None
2012-03-21 Malfunction None None
2012-03-21 Malfunction None None
2012-03-21 Injury None None
2012-03-16 Injury None None
2012-03-15 Death None None
2012-03-13 Injury None None
2012-03-09 Injury None None
2012-03-07 Death None None
2012-03-05 Injury None None
2012-03-02 Injury None None
2012-02-29 Death None None
2012-02-26 Injury None None
2012-02-24 Malfunction None None
2012-01-30 Injury None None
2012-01-27 Injury None None
2012-01-26 Injury None None
2012-01-25 Injury None None
2012-01-11 Injury None None
2012-01-05 Injury None None
2012-01-05 Death None None
2012-01-04 Malfunction None None
2012-01-04 Injury None None
2011-12-06 Death None None
2011-12-05 Injury None None
2011-11-29 Injury None None
2011-11-26 Injury None None
2011-11-18 Injury None None
2011-11-12 Injury None None
2011-11-10 Injury None None
2011-11-03 Injury None None
2011-10-31 Malfunction None None
2011-10-31 Injury None None
2011-10-27 Injury None None
2011-10-26 Death None None
2011-10-13 Death None None
2011-10-12 Malfunction None None
2011-10-12 Injury None None
2011-09-15 Injury None None
2011-08-30 Injury None None
2011-08-02 Injury None None
2011-07-16 Injury None None
2011-07-04 Injury None None
2011-07-03 Injury None None
2011-06-22 Malfunction None None
2011-06-02 Death None None
2011-05-22 Malfunction None None
2011-05-20 Injury None None
2011-05-17 Malfunction None None
2011-05-17 Injury None None
2011-05-05 Injury None None
2011-04-20 Malfunction None None
2011-04-15 Injury None None
2011-03-24 Injury None None
2011-03-19 Death None None
2011-03-14 Injury None None
2011-03-09 Malfunction None None
2011-03-05 Malfunction None None
2011-02-03 Malfunction None None
2011-01-27 Malfunction None None
2011-01-27 Injury None None
2011-01-22 Injury None None
2011-01-10 Death None None
2010-12-21 Injury None None
2010-11-09 Injury None None
2010-10-14 Malfunction None None
2010-09-09 Injury None None
2010-07-04 Injury None None
2010-07-01 Injury None None
2010-06-29 Injury None None
2010-04-17 Death None None
2010-04-14 Death None None
2010-02-28 Injury None None
2010-02-14 Injury None None
2010-02-13 Injury None None
2009-12-31 Injury None None