FDA Adverse Event
Death
Summary report: N
R SERIES DEFIBRILLATOR
MDR report key: 2954257
·
Received January 28, 2013
Report
- Report Number
- 1220908-2013-00083
- Event Type
- Death
- Date Received
- January 28, 2013
- Report Date
- January 8, 2013
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K060559
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 WHILE ATTEMPTING TO DEFIBRILLATE A MALE PATIENT (AGE UNKNOWN) DURING OPEN HEART SURGERY, THE DEVICE WAS UNABLE TO DISCHARGE VIA INTERNAL PADDLES. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. PLEASE REFERENCE MEDWATCH REPORT 1220908-2013-00084 FOR THE REPORT RELATED TO THE SECOND DEFIBRILLATOR. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36854 | R SERIES DEFIBRILLATOR | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | R SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |