FDA Adverse Event
Malfunction
Summary report: N
R SERIES DEFIBRILLATOR
MDR report key: 5243921
·
Received November 23, 2015
Report
- Report Number
- 1220908-2015-03056
- Event Type
- Malfunction
- Date Received
- November 23, 2015
- Report Date
- November 6, 2015
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- DRO
- PMA / PMN Number
- K060559
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER WAS CONTACTED FOR THE RETURN OF THE PRODUCT. THE CUSTOMER RESPONDED AND STATED THE DEVICE WILL NOT BE RETURNED TO ZOLL FOR EVALUATION. THE DEVICE WAS REPAIRED AND RETURNED TO SERVICE FOR CLINICAL USE.
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 A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS INTERMITTENTLY UNABLE TO INCREASE PACER OUTPUT OR ADJUST PACER RATE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 775186 | R SERIES DEFIBRILLATOR | DEFIBRILLATOR/PACEMAKER | DRO | ZOLL MEDICAL CORPORATION | R SERIES | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |