FDA Adverse Event
Malfunction
Summary report: N
AED PRO
MDR report key: 1993619
·
Received January 26, 2011
Report
- Report Number
- 1220908-2011-00094
- Event Type
- Malfunction
- Date Received
- January 26, 2011
- Date of Event
- January 4, 2011
- Report Date
- January 5, 2011
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS RECEIVED THE PRODUCT 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 DEFIBRILLATE A (B)(6), MALE PT, THE DEVICE PROMPTED AN "UNABLE TO SHOCK" MESSAGE. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AED PRO | DEFIBRILLATOR | MKJ | ZOLL MEDICAL CORPORATION | AED PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Death |