FDA Adverse Event
Malfunction
Summary report: N
R SERIES DEFIBRILLATOR
MDR report key: 3095702
·
Received April 18, 2013
Report
- Report Number
- 1220908-2013-00976
- Event Type
- Malfunction
- Date Received
- April 18, 2013
- Date of Event
- March 29, 2013
- Report Date
- April 2, 2013
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K060559
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS NOT RECEIVED THE DEVICE FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A MALE PT (AGE UNK), THE PACKAGE OF ELECTRODE PADS WERE DIFFICULT TO OPEN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER PACKAGE OF ELECTRODE PADS FROM THE SAME LOT TO CONTINUE TREATING THE PT AND THEY WORKED FINE. 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 |
|---|---|---|---|---|---|---|---|
| 167640 | R SERIES DEFIBRILLATOR | R SERIES | MKJ | ZOLL MEDICAL CORPORATION | R SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |