FDA Adverse Event
Malfunction
Summary report: N
M SERIES
MDR report key: 1024173
·
Received March 25, 2008
Report
- Report Number
- 1220908-2008-00577
- Event Type
- Malfunction
- Date Received
- March 25, 2008
- Date of Event
- March 4, 2008
- Report Date
- March 5, 2008
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS RECEIVED 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 PACE A FEMALE PT THE DEVICE PACER RATE WAS ERRATIC. THE RATE WAS SET TO 108 PPM (PULSES PER MINUTE) AND SELF-ADJUSTED TO 140 PPM. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY 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 CORPORATION | MSERIES BI-PHASIC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR |