FDA Adverse Event
Malfunction
Summary report: N
E SERIES DEFIBRILLATOR
MDR report key: 4423704
·
Received January 9, 2015
Report
- Report Number
- 1220908-2014-03341
- Event Type
- Malfunction
- Date Received
- January 9, 2015
- Report Date
- December 22, 2014
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K042007
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (GENDER AND AGE UNKNOWN), THE DEVICE ISSUED A "NO SHOCK ADVISED" PROMPT FOR A HEART RHYTHM THEY BELIEVE WAS SHOCKABLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. SUBSEQUENT TESTING ON A SIMULATOR DID NOT DUPLICATE THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH NUMBER 122098-2014-03354 FOR A SIMILAR OCCURRENCE ON A DIFFERENT PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23849 | E SERIES DEFIBRILLATOR | E SERIES | MKJ | ZOLL MEDICAL CORPORATION | E SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |