GENERATOR
This device is manufactured by HILL-ROM, HILL-ROM SERVICES PRIVATE LIMITED, LIVANOVA USA, STRYKER CORP MEDICAL DIVISION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Insufficient Information | 2 | Patient |
| 2024 | Convulsion, Clonic | 1 | Patient |
| 2024 | Material Rupture | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Unspecified Heart Problem | 1 | Patient |
| 2023 | Failure to Interrogate | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2022 | Convulsion, Clonic | 1 | Patient |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Fracture | 1 | Device |
| 2022 | Detachment of Device or Device Component | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2019 | Premature End-of-Life Indicator | 6 | Device |
| 2019 | Physical Resistance/Sticking | 1 | Device |
| 2019 | Mechanical Problem | 1 | Device |
| 2019 | Material Rupture | 6 | Device |
| 2019 | Entrapment of Device | 1 | Device |
| 2019 | Energy Output Problem | 2 | Device |
| 2019 | Burst Container or Vessel | 1 | Device |
| 2019 | Break | 1 | Device |
| 2019 | Appropriate Term/Code Not Available | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 44 | Device |
| 2018 | Convulsion, Clonic | 1 | Patient |
| 2018 | Premature End-of-Life Indicator | 9 | Device |
| 2018 | Physical Resistance/Sticking | 1 | Device |
| 2018 | Material Rupture | 5 | Device |
| 2018 | Leak/Splash | 1 | Device |
| 2018 | Insufficient Information | 3 | Device |
| 2018 | High impedance | 1 | Device |
| 2018 | Energy Output To Patient Tissue Incorrect | 2 | Device |
| 2018 | Energy Output Problem | 3 | Device |
| 2018 | Difficult to Open or Close | 1 | Device |
| 2018 | Device Contaminated During Manufacture or Shipping | 1 | Device |
| 2018 | Detachment of Device or Device Component | 1 | Device |
| 2018 | Detachment Of Device Component | 1 | Device |
| 2018 | Crack | 1 | Device |
| 2018 | Burst Container or Vessel | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 93 | Device |
| 2017 | Premature End-of-Life Indicator | 7 | Device |
| 2017 | Migration or Expulsion of Device | 1 | Device |
| 2017 | Material Separation | 1 | Device |
| 2017 | Material Rupture | 5 | Device |
| 2017 | Material Protrusion/Extrusion | 1 | Device |
| 2017 | Material Erosion | 1 | Device |
| 2017 | Insufficient Information | 3 | Device |
| 2017 | High impedance | 9 | Device |
| 2017 | Fracture | 3 | Device |
| 2017 | Fluid/Blood Leak | 1 | Device |
| 2017 | Energy Output To Patient Tissue Incorrect | 2 | Device |
| 2017 | Detachment Of Device Component | 2 | Device |
| 2017 | Communication or Transmission Problem | 3 | Device |
| 2017 | Burst Container or Vessel | 1 | Device |
| 2017 | Appropriate Term/Code Not Available | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 47 | Device |
| 2016 | Unexpected Therapeutic Results | 3 | Device |
| 2016 | Programming Issue | 1 | Device |
| 2016 | Premature End-of-Life Indicator | 3 | Device |
| 2016 | Premature Discharge of Battery | 1 | Device |
| 2016 | Power Problem | 1 | Device |
| 2016 | Pocket Stimulation | 1 | Device |
| 2016 | No Display/Image | 1 | Device |
| 2016 | Malposition of Device | 1 | Device |
| 2016 | Insufficient Information | 7 | Device |
| 2016 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2016 | High impedance | 3 | Device |
| 2016 | Fracture | 1 | Device |
| 2016 | Failure to Reset | 1 | Device |
| 2016 | Extrusion | 1 | Device |
| 2016 | Entrapment of Device | 1 | Device |
| 2016 | Energy Output To Patient Tissue Incorrect | 1 | Device |
| 2016 | Device Operates Differently Than Expected | 2 | Device |
| 2016 | Device Inoperable | 2 | Device |
| 2016 | Device Expiration Issue | 1 | Device |
| 2016 | Device Displays Incorrect Message | 1 | Device |
| 2016 | Communication or Transmission Problem | 2 | Device |
| 2016 | Burst Container or Vessel | 2 | Device |
| 2016 | Battery Problem | 5 | Device |
| 2016 | Appropriate Term/Code Not Available | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 29 | Device |
| 2015 | Aspiration/Inhalation | 1 | Patient |
| 2015 | Unexpected Therapeutic Results | 1 | Device |
| 2015 | Sticking | 1 | Device |
| 2015 | Programming Issue | 1 | Device |
| 2015 | Premature End-of-Life Indicator | 36 | Device |
| 2015 | Output Problem | 1 | Device |
| 2015 | Migration or Expulsion of Device | 1 | Device |
| 2015 | Material Protrusion/Extrusion | 1 | Device |
| 2015 | Insufficient Information | 4 | Device |
| 2015 | Impedance Problem | 1 | Device |
| 2015 | High impedance | 2 | Device |
| 2015 | Failure to Deliver Energy | 1 | Device |
| 2015 | Device Operates Differently Than Expected | 2 | Device |
| 2015 | Device Contaminated During Manufacture or Shipping | 14 | Device |
| 2015 | Defective Component | 1 | Device |
| 2015 | Burst Container or Vessel | 1 | Device |
| 2015 | Battery Problem | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 17 | Device |
| 2014 | Impaired Healing | 1 | Patient |
| 2014 | Use of Incorrect Control/Treatment Settings | 2 | Device |
| 2014 | Unexpected Therapeutic Results | 1 | Device |
| 2014 | Protective Measures Problem | 1 | Device |
| 2014 | Programming Issue | 4 | Device |
| 2014 | Positioning Problem | 3 | Device |
| 2014 | Migration or Expulsion of Device | 2 | Device |
| 2014 | Microbial Contamination of Device | 1 | Device |
| 2014 | Mechanical Problem | 1 | Device |
| 2014 | Material Protrusion/Extrusion | 1 | Device |
| 2014 | Malposition of Device | 3 | Device |
| 2014 | Low impedance | 1 | Device |
| 2014 | Loose or Intermittent Connection | 1 | Device |
| 2014 | Insufficient Information | 26 | Device |
| 2014 | Increased Sensitivity | 1 | Device |
| 2014 | Improper or Incorrect Procedure or Method | 6 | Device |
| 2014 | Hole In Material | 1 | Device |
| 2014 | High impedance | 16 | Device |
| 2014 | Fracture | 1 | Device |
| 2014 | Failure to Sense | 1 | Device |
| 2014 | Failure to Interrogate | 3 | Device |
| 2014 | Failure to Advance | 1 | Device |
| 2014 | Failure of Device to Self-Test | 1 | Device |
| 2014 | Electrical /Electronic Property Problem | 1 | Device |
| 2014 | Disconnection | 1 | Device |
| 2014 | Difficult to Interrogate | 1 | Device |
| 2014 | Device Operates Differently Than Expected | 3 | Device |
| 2014 | Device Inoperable | 2 | Device |
| 2014 | Device Displays Incorrect Message | 1 | Device |
| 2014 | Device Contamination with Body Fluid | 1 | Device |
| 2014 | Detachment of Device or Device Component | 1 | Device |
| 2014 | Contamination | 1 | Device |
| 2014 | Burst Container or Vessel | 2 | Device |
| 2014 | Break | 1 | Device |
| 2014 | Battery Problem | 2 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 26 | Device |
| 2013 | Use of Incorrect Control/Treatment Settings | 1 | Device |
| 2013 | Programming Issue | 1 | Device |
| 2013 | Output below Specifications | 1 | Device |
| 2013 | Migration or Expulsion of Device | 1 | Device |
| 2013 | Material Protrusion/Extrusion | 2 | Device |
| 2013 | Insufficient Information | 11 | Device |
| 2013 | High impedance | 3 | Device |
| 2013 | Burst Container or Vessel | 1 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 3 | Device |