FDA Adverse Event
Death
Summary report: N
AED PLUS
MDR report key: 1062567
·
Received June 18, 2008
Report
- Report Number
- 1220908-2008-01250
- Event Type
- Death
- Date Received
- June 18, 2008
- Date of Event
- May 17, 2008
- Report Date
- May 23, 2008
- Manufacturer
- ZOLL MEDICAL CORP
- Product Code
- MKJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PARAMEDIC
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS REC'D THE PROD AND WILL BE PROVIDING A F/U REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A MALE PT, THE DEVICE ADVISED TREATMENT AND THEN PROMPTED A "CHECK BATTERIES" MESSAGE. THE DEVICE AGAIN ADVISED TREATMENT AND THEN PROMPTED A "TREATMENT NOT DELIVERED" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AED PLUS | DEFIBRILLATOR | MKJ | ZOLL MEDICAL CORP | AED PLUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Death |