FDA Adverse Event
Malfunction
Summary report: N
R SERIES DEFIBRILLATOR
MDR report key: 3844762
·
Received March 12, 2014
Report
- Report Number
- 1220908-2014-00588
- Event Type
- Malfunction
- Date Received
- March 12, 2014
- Report Date
- February 24, 2014
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K060559
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING ROUTINE TESTING BY A ZOLL MEDICAL SALES REPRESENTATIVE, THE DEVICE WAS UNABLE TO SWITCH FROM PACE TO DEFIB MODE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149357 | R SERIES DEFIBRILLATOR | DEFIBRILLATOR.PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | R SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |