FDA Adverse Event
Death
Summary report: N
LIFELINE AED
MDR report key: 1153191
·
Received September 5, 2008
Report
- Report Number
- 3003521780-2008-00011
- Event Type
- Death
- Date Received
- September 5, 2008
- Date of Event
- August 6, 2008
- Report Date
- August 7, 2008
- Manufacturer
- DEFIBTECH, LLC
- Product Code
- MKJ
- Removal / Correction Number
- Z-0580-2007, Z-0581-2007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUMMARY: THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. BASED ON THE EVALUATION, THE SOFTWARE INCORRECTLY CLEARED A LOW BATTERY WARNING, AS ADDRESSED IN RECALL. ALSO, SERVICE/MAINTENANCE OF THE DEVICE WAS NOT FOLLOWED ACCORDING TO THE MFR'S RECOMMENDATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A RESCUE ATTEMPT, THE DEVICE INDICATED A LOW BATTERY CONDITION. THE PT WAS TRANSFERRED TO ANOTHER DEFIBRILLATOR. IT WAS REPORTED THAT THE PT DID NOT SURVIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFELINE AED | SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR | MKJ | DEFIBTECH, LLC | DDU-100A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Death |