FDA Adverse Event
Malfunction
Summary report: N
M SERIES
MDR report key: 2081711
·
Received April 12, 2011
Report
- Report Number
- 1220908-2011-01165
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Report Date
- March 18, 2011
- Manufacturer
- ZOLL MEDICAL CORP.
- Product Code
- MKJ
- PMA / PMN Number
- K011865
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP. 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 DEVICE FAILED GROUND RESISTANCE TESTING. 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 CCT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |