FDA Adverse Event
Malfunction
Summary report: N
PROQPAQ MD DEFIBRILLATOR
MDR report key: 2943425
·
Received January 8, 2013
Report
- Report Number
- 1220908-2012-03610
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Date of Event
- December 22, 2012
- Report Date
- December 26, 2012
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- LDD
- PMA / PMN Number
- K100654
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS REC'D 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 TREAT A PT, THE DEVICE'S DISPLAY BLANKED OUT. THE CLINICIAN REPLACED THE BATTERY AND THE DEVICE WOULD NOT POWER UP. 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 |
|---|---|---|---|---|---|---|---|
| 10302 | PROQPAQ MD DEFIBRILLATOR | DEFIBRILLATOR/PACEMAKER | LDD | ZOLL MEDICAL CORPORATION | PROPAQ MD | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |