FDA Adverse Event
Malfunction
Summary report: N
POWER HEART G3 AED BATTERY
MDR report key: 1151951
·
Received September 5, 2008
Report
- Report Number
- MW5008221
- Event Type
- Malfunction
- Date Received
- September 5, 2008
- Report Date
- September 5, 2008
- Manufacturer
- CARDIAC SCIENCE
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BATTERIES IN CARDIAC SCIENCE POWER HEART G3 AED HAS STOPPED WORKING. THE MFR SAID THEY WILL REPLACE THE BATTERIES BECAUSE THERE IS A FREE REPLACEMENT IF THE BATTERY FAILS TO WORK DURING THIS 4 YEAR GUARANTEE. MY PROBLEM IS THAT THE BATTERY SHOULD EITHER LAST FOR THE 4 YEARS OR, THE UNIT SHOULD SIGNAL YOU IN ADVANCE THAT THE BATTERIES ARE ALMOST DEAD. THE UNIT WAS BEEPING BUT I WOULD LIKE TO BE ASSURED IN THE EVENT OF AN EMERGENCY TO HAVE THIS AVAILABLE IF NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWER HEART G3 AED BATTERY | AED BATTERY | MKJ | CARDIAC SCIENCE | 9146 | 10194-163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |