FDA Adverse Event
Death
Summary report: N
M SERIES
MDR report key: 960638
·
Received December 5, 2007
Report
- Report Number
- 1220908-2007-02669
- Event Type
- Death
- Date Received
- December 5, 2007
- Date of Event
- November 5, 2007
- Report Date
- November 19, 2007
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS NOT REC'D THE DEVICE FOR EVAL, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN UNRECOGNIZED "DEFIB FAULT NOT CHARGED" ERROR MESSAGE. 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 | M SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | MSERIES BI-PHASIC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Death |