FDA Adverse Event
Malfunction
Summary report: N
E SERIES DEFIBRILLATOR
MDR report key: 4423717
·
Received January 9, 2015
Report
- Report Number
- 1220908-2014-03354
- Event Type
- Malfunction
- Date Received
- January 9, 2015
- Report Date
- December 22, 2014
- 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 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. COMPLAINANT INDICATED THAT THIS IS THE SECOND OCCURRENCE REPORTED; PLEASE REFERENCE MEDWATCH NUMBER 122098-2014-03341 FOR THE FIRST OCCURRENCE ON DIFFERENT PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24016 | E SERIES DEFIBRILLATOR | E SERIES | MKJ | ZOLL MEDICAL CORPORATION | E SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |