FDA Adverse Event
Malfunction
Summary report: N
X SERIES
MDR report key: 3101433
·
Received April 29, 2013
Report
- Report Number
- 1220908-2013-01047
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Report Date
- April 12, 2013
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K112432
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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 DEVICE DISPLAYED A "PACE DEFIB DEVICE FAILURE" MESSAGE. THE CLINICIANS TURNED OFF THE DEVICE AND WERE UNABLE TO POWER BACK UP. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184418 | X SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | X SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |