FDA Adverse Event
Malfunction
Summary report: N
R SERIES DEFIBRILLATOR
MDR report key: 2090657
·
Received April 19, 2011
Report
- Report Number
- 1220908-2011-01052
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 25, 2011
- Report Date
- March 30, 2011
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K060559
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS REC'D THE PRODUCT AND WILL BE PROVIDING A F/U REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING A SYNCHRONIZED CARDIOVERSION ON A PT, THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | R SERIES DEFIBRILLATOR | DEFIBRILLLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | R SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |