FDA Adverse Event
Malfunction
Summary report: N
M SERIES
MDR report key: 564450
·
Received December 31, 2004
Report
- Report Number
- 1220908-2004-02782
- Event Type
- Malfunction
- Date Received
- December 31, 2004
- Report Date
- December 27, 2004
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DURING FUNCTIONAL TESTING AT ZOLL MEDICAL CORPORATION, THE DEVICE DISPLAYED A "PACER FAULT 121, 122, 123, AND 126" MESSAGE. THERE WAS NO PATIENT INVOLVEMENT DURING THE 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 | NA | Other |