FDA Adverse Event
Death
Summary report: N
E SERIES DEFIBRILLATOR
MDR report key: 1952218
·
Received January 3, 2011
Report
- Report Number
- 1220908-2010-03725
- Event Type
- Death
- Date Received
- January 3, 2011
- Date of Event
- December 9, 2010
- Report Date
- December 14, 2010
- Manufacturer
- ZOLL MEDICAL CORP
- Product Code
- MKJ
- PMA / PMN Number
- K042007
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A (B)(6) MALE PT FOR CARDIAC ARREST, THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT AN "ERROR MESSAGE" APPEARED, BUT THEY DID NOT KNOW WHAT ONE. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | E SERIES DEFIBRILLATOR | E SERIES | MKJ | ZOLL MEDICAL CORP | E SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Death |