FDA Adverse Event
Malfunction
Summary report: N
M SERIES
MDR report key: 1080154
·
Received July 17, 2008
Report
- Report Number
- 1220908-2008-01533
- Event Type
- Malfunction
- Date Received
- July 17, 2008
- Report Date
- June 30, 2008
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED MALFUNCTION WAS OBSERVED AND ATTRIBUTED TO A MISALIGNED BIPHASIC FLEX CABLE. ANALYSIS OF FAILURES OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "UNIT FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT 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 |