FDA Adverse Event
Death
Summary report: N
AED PLUS
MDR report key: 835412
·
Received April 4, 2007
Report
- Report Number
- 1220908-2007-00681
- Event Type
- Death
- Date Received
- April 4, 2007
- Date of Event
- February 14, 2007
- Report Date
- March 19, 2007
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT REC'D THE PRODUCT AND THIS COMPLAINT IS STILL UNDER INVESTIGATION. THE COMPLAINANT INDICATED THAT THIS DEVICE WAS USED IN TWO OTHER INCIDENTS WHICH ARE BEING REPORTED UNDER MEDWATCH 1220908-2007-00761 AND 1220908-2007-00762.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PT, THE DEVICE GAVE A "SHOCK ADVISED" PROMPT; HOWEVER, WOULD NOT ALLOW DISCHARGE. 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 |