FDA Adverse Event
Malfunction
Summary report: N
M SERIES
MDR report key: 1062153
·
Received June 13, 2008
Report
- Report Number
- 1220908-2008-01266
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Report Date
- June 2, 2008
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP EVALUATED THE DEVICE AND THE REPORTED MALFUNCTION WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING, WHICH INCLUDED ENVIRONMENTAL AND FUNCTIONAL TESTING WITHOUT DUPLICATING THE MALFUNCTION. THE EL DISPLAY WAS REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN 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 |