FDA Adverse Event
Malfunction
Summary report: N
M SERIES
MDR report key: 732724
·
Received June 22, 2006
Report
- Report Number
- 1220908-2006-01362
- Event Type
- Malfunction
- Date Received
- June 22, 2006
- Report Date
- June 20, 2006
- Manufacturer
- ZOLL MEDICAL CORP
- Product Code
- MKJ
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS NOT RECEIVED THE PRODUCT AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING BIOMEDICAL TESTING THE DEVICE DISPLAYED "PACER FAULT 116," "SYSTEM FAULT 36," "DEFIB DISABLED," AND "PACER DISABLED" MESSAGES ON POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | M SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORP | MSERIES BI-PHASIC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |