FDA Adverse Event
Death
Summary report: N
AED PLUS
MDR report key: 831823
·
Received February 27, 2007
Report
- Report Number
- 1220908-2007-00397
- Event Type
- Death
- Date Received
- February 27, 2007
- Date of Event
- February 2, 2007
- Report Date
- February 15, 2007
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS NOT REC'D THE PRODUCT AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PT (AGE & GENDER UNK), THE DEVICE WOULD NOT ALLOW DISCHARGE AND GAVE A "LOW BATTERY" 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 CORPORATION | AED PLUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Death |