FDA Adverse Event
Death
Summary report: N
AED PLUS
MDR report key: 1171043
·
Received September 19, 2008
Report
- Report Number
- 1220908-2008-02142
- Event Type
- Death
- Date Received
- September 19, 2008
- Date of Event
- August 5, 2008
- Report Date
- September 4, 2008
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, 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 TREAT A MALE PT IN CARDIAC ARREST, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED, HOWEVER, IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AED PLUS | DEFIBRILLATOR | MKJ | ZOLL MEDICAL CORPORATION | AED PLUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Death |