FDA Adverse Event
Malfunction
Summary report: N
R SERIES DEFIBRILLATOR
MDR report key: 3830366
·
Received May 12, 2014
Report
- Report Number
- 1220908-2014-01159
- Event Type
- Malfunction
- Date Received
- May 12, 2014
- Report Date
- April 24, 2014
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K060559
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING TRAINING BY FACILITY STAFF. THE DEVICE DISPLAYED "DEFIB FAULT 76" "DEFIB FAULT 72", AND "DEFIB DISABLED" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283395 | R SERIES DEFIBRILLATOR | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | R SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |