FDA Adverse Event
Malfunction
Summary report: N
M SERIES
MDR report key: 1061780
·
Received June 13, 2008
Report
- Report Number
- 1220908-2008-01240
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Report Date
- May 28, 2008
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED MALFUNCTION WAS OBSERVED AND ATTRIBUTED TO A FAULTY INSULATED GATE BI-POLAR TRANSISTOR ON THE BRIDGE BOARD. TREND ANALYSIS FOR FAILURES OF THIS TYPE DOES NOT INDICATE AN INCREASE IN FREQUENCY.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "BRIDGE TEST FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | M SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | M SERIES BI-PHASIC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |