FDA Adverse Event
Malfunction
Summary report: N
E SERIES DEFIBRILLATOR
MDR report key: 2942216
·
Received January 3, 2013
Report
- Report Number
- 1220908-2012-03634
- Event Type
- Malfunction
- Date Received
- January 3, 2013
- Date of Event
- December 11, 2012
- Report Date
- December 19, 2012
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K042007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS NOT RECEIVED THE DEVICE FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PT, THE DEVICE'S DISPLAY HAD LINES THROUGH THE SCREEN AND CRITICAL INFO COULD NOT BE READ. 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 |
|---|---|---|---|---|---|---|---|
| 3260 | E SERIES DEFIBRILLATOR | E SERIES | MKJ | ZOLL MEDICAL CORPORATION | E SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |