FDA Adverse Event
Malfunction
Summary report: N
M SERIES
MDR report key: 1000576
·
Received February 15, 2008
Report
- Report Number
- 1220908-2008-00341
- Event Type
- Malfunction
- Date Received
- February 15, 2008
- Date of Event
- February 5, 2008
- Report Date
- February 6, 2008
- Manufacturer
- ZOLL MEDICAL CORP
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE MALFUNCTION WAS DUPLICATED AND ATTRIBUTED TO A DAMAGED KNOB THAT WASN'T SEATED PROPERLY.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PT, THE DEVICE'S PACER OUTPUT RESETS TO ZERO. 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 |
|---|---|---|---|---|---|---|---|
| 1 | M SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORP | MSERIES BI-PHASIC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |