FDA Adverse Event
Malfunction
Summary report: N
M SERIES
MDR report key: 1030488
·
Received April 16, 2008
Report
- Report Number
- 1220908-2008-00755
- Event Type
- Malfunction
- Date Received
- April 16, 2008
- Date of Event
- March 31, 2008
- Report Date
- March 31, 2008
- Manufacturer
- ZOLL MEDICAL CORP
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS NOT REC'D THE PRODUCT, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PT, THE DEVICE WOULD NOT DISCHARGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION. COMPLAINANT INDICATED THAT DURING SUBSEQUENT BIOMED TESTING, THE DEVICE DISPLAYED "BRIDGE TEST FAIL" AND "DISCHARGE FAULT" MESSAGES.
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 |