AUTOPULSE RESUSCITATION SYSTEM MODEL 100

CARDIAC CHEST COMPRESSOR

This device is manufactured by HEARTWARE, LIVANOVA USA, MEDTRONIC, MEDTRONIC HEART VALVES DIVISION, PHILIPS and others.

The following problems were reported about this device:

Year Description Events/year Type
2024 Insufficient Information 4 Patient
2024 Visual Prompts will not Clear 5 Device
2024 Use of Device Problem 1 Device
2023 Insufficient Information 18 Patient
2023 Visual Prompts will not Clear 29 Device
2023 Use of Device Problem 7 Device
2023 Unexpected Shutdown 1 Device
2023 Retraction Problem 2 Device
2023 Noise, Audible 2 Device
2023 No Display/Image 2 Device
2023 Material Integrity Problem 1 Device
2023 Intermittent Loss of Power 1 Device
2023 Fitting Problem 1 Device
2023 Erratic or Intermittent Display 1 Device
2023 Display or Visual Feedback Problem 3 Device
2023 Break 1 Device
2019 Pumping Stopped 1 Device
2019 Obstruction of Flow 1 Device
2019 Material Integrity Problem 1 Device
2019 Electrical /Electronic Property Problem 2 Device
2019 Difficult to Remove 1 Device
2019 Connection Problem 1 Device
2019 Appropriate Term/Code Not Available 3 Device
2018 Smoking 1 Device
2018 Mechanical Problem 1 Device
2018 Loss of Power 1 Device
2018 Gradient Increase 1 Device
2018 Electrical /Electronic Property Problem 2 Device
2018 Disconnection 1 Device
2018 Device Emits Odor 1 Device
2018 Complete Blockage 1 Device
2018 Adverse Event Without Identified Device or Use Problem 1 Device
2017 Insufficient Information 3 Device
2017 Device Operates Differently Than Expected 1 Device
2016 Material Too Rigid or Stiff 1 Device
2016 Insufficient Information 1 Device
2016 Incorrect, Inadequate or Imprecise Result or Readings 1 Device
2016 Incomplete Coaptation 1 Device
2016 Gradient Increase 3 Device
2016 Fluid/Blood Leak 1 Device
2016 Device Operates Differently Than Expected 1 Device
2016 Contamination 1 Device
2016 Break 1 Device
2016 Battery Problem 1 Device
2015 Insufficient Information 1 Device
2015 Failure to Interrogate 1 Device
2014 Insufficient Information 2 Device
2014 Incorrect Or Inadequate Test Results 1 Device
2014 Gradient Increase 1 Device
2014 Break 1 Device
2013 No Display/Image 2 Device
2013 Leak/Splash 1 Device
2013 Fluid/Blood Leak 1 Device
2013 Crack 2 Device
2013 Battery Problem 2 Device
2012 Gradient Increase 2 Device
2012 Device Operates Differently Than Expected 1 Device
2012 Delamination 1 Device
2010 Obstruction of Flow 1 Device
2010 Gradient Increase 1 Device
2010 Calcified 1 Device
2004 Failure to Interrogate 1 Device
2002 Adverse Event Without Identified Device or Use Problem 2 Device
2001 Adverse Event Without Identified Device or Use Problem 2 Device
2000 Insufficient Information 1 Device
2000 Adverse Event Without Identified Device or Use Problem 1 Device
1999 Adverse Event Without Identified Device or Use Problem 2 Device
1998 Convulsion, Clonic 1 Patient
1998 Adverse Event Without Identified Device or Use Problem 2 Device
1995 Adverse Event Without Identified Device or Use Problem 1 Device
1981 Obstruction of Flow 1 Device
1981 Material Split, Cut or Torn 1 Device
1981 Incomplete Coaptation 1 Device
1981 Gradient Increase 1 Device
1981 Degraded 1 Device
1981 Calcified 1 Device