FDA Adverse Event
Malfunction
Summary report: N
M SERIES
MDR report key: 2083232
·
Received April 13, 2011
Report
- Report Number
- 1220908-2011-00943
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Report Date
- March 23, 2011
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K990762
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED MALFUNCTION WAS OBSERVED AND THE EL DISPLAY WAS REPLACED TO REMEDY THE PROBLEM CONDITION. ANALYSIS OF REPORTS 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'S DISPLAY WAS ORANGE AND NOT LEGIBLE. 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 |