FDA Adverse Event
Death
Summary report: N
PROPAQ MD DEFIBRILLATOR
MDR report key: 2771851
·
Received September 27, 2012
Report
- Report Number
- 1220908-2012-02560
- Event Type
- Death
- Date Received
- September 27, 2012
- Date of Event
- September 5, 2012
- Report Date
- September 11, 2012
- Manufacturer
- ZOLL MEDICAL CORP
- Product Code
- MKJ
- PMA / PMN Number
- K100654
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP 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 PT, THE DEVICE PROMPTED A "CHECK PADS" MESSAGE. THE CLINICIAN SWITCHED DEFIB ELECTRODES AND THE DEVICE PROMPTED A "CHECK PADS" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED; HOWEVER, IT WAS NOT RELATED TO THE REPORTED MALFUNCTION. COMPLAINANT INDICATED THAT DURING SUBSEQUENT TESTING, THE MALFUNCTION WAS NOT DUPLICATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROPAQ MD DEFIBRILLATOR | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORP | PROPAQ MD | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |