FDA Adverse Event
Malfunction
Summary report: N
M SERIES
MDR report key: 2083213
·
Received April 13, 2011
Report
- Report Number
- 1220908-2011-00919
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Report Date
- March 23, 2011
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K972241
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE BATTERY BECAME HOT AND WARPED THE HOUSING AND THEY WERE NOT ABLE TO SEAT THE BATTERY INTO THE DEVICE. 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 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |