FDA Adverse Event
Malfunction
Summary report: N
R SERIES DEFIBRILLATOR
MDR report key: 2182119
·
Received June 23, 2011
Report
- Report Number
- 1220908-2011-01715
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 1, 2011
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K060559
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A F/U REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) MALE PT, THE DEVICE DISPLAYED A "DEFIB DISABLED" MESSAGE. THE DEVICE WAS RECHARGED AND THE UNIT SUCCESSFULLY DISCHARGED. 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 | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | R SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |