FDA Adverse Event
Death
Summary report: N
1600 SEMI AUTOMATIC DEFIBRILLATOR
MDR report key: 822979
·
Received February 28, 2007
Report
- Report Number
- 1220908-2007-00433
- Event Type
- Death
- Date Received
- February 28, 2007
- Date of Event
- February 15, 2007
- Report Date
- February 16, 2007
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, 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 PT (AGE & GENDER UNK) THE DEVICE DISPLAYED A "STATUS 93" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THE PT SUBSEQUENT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1600 SEMI AUTOMATIC DEFIBRILLATOR | DEFIBRILLATOR | MKJ | ZOLL MEDICAL CORPORATION | 1600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Death |