FDA Adverse Event
Malfunction
Summary report: N
M SERIES
MDR report key: 1062682
·
Received June 18, 2008
Report
- Report Number
- 1220908-2008-01194
- Event Type
- Malfunction
- Date Received
- June 18, 2008
- Report Date
- May 21, 2008
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP EVALUATED THE DEVICE. THE DEVICE WENT THROUGH ELECTRICAL, LEAKAGE AND FUNCTIONAL TEST AND PERFORMED TO SPECIFICATION. TREND ANALYSIS FOR REPORTS OF THIS TYPE DOES NOT INDICATE AN INCREASE IN FREQUENCY.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE THE NURSE WAS TRANSPORTING, THE DEVICE SHE FELT A SHOCK. COMPLAINANT INDICATED THAT IT MAY HAVE BEEN A STATIC-ELECTRIC SHOCK. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE NURSE DUE TO THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | M SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | MSERIES BI-PHASIC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |