FDA Adverse Event
Malfunction
Summary report: N
M SERIES
MDR report key: 2091159
·
Received May 10, 2011
Report
- Report Number
- 1220908-2011-01298
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Report Date
- April 19, 2011
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K990762
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
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 FUZZY AND THE CLINICAL INFO AT THE BOTTOM WAS UNABLE TO BE SEEN. 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 |