FDA Adverse Event
Malfunction
Summary report: N
M SERIES
MDR report key: 1052195
·
Received May 20, 2008
Report
- Report Number
- 1220908-2008-01004
- Event Type
- Malfunction
- Date Received
- May 20, 2008
- Report Date
- April 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 DEVICE WAS NOT RETURNED TO ZOLL. THE CUSTOMER ATTRIBUTED THE MALFUNCTION TO THE DEVICE'S HV MODULE AND BRIDGE BOARD. THE HV MODULE AND BRIDGE BOARD WERE RETURNED TO ZOLL AND THE MALFUNCTION WAS NOT DUPLICATED. THE CUSTOMER INDICATED THAT REPLACING THE MODULE RESOLVED THE MALFUNCTION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK, THE DEVICE DISPLAYED "BRIDGE TEST FAIL" AND "DEFIB FAULT 80" MESSAGES. 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 CORPORATION | MSERIES BI-PHASIC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |