FDA Adverse Event
Malfunction
Summary report: N
E SERIES DEFIBRILLATOR
MDR report key: 3101444
·
Received April 29, 2013
Report
- Report Number
- 1220908-2013-01003
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Report Date
- April 10, 2013
- Manufacturer
- ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
- 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 DURING FUNCTIONAL TESTING, THE DEVICE'S DISPLAY BLANKED OUT. COMPLAINANT INDICATED THAT DURING FURTHER TESTING, "SYSTEM FAULT 14" AND "SYSTEM FAULT 33" WERE SEEN IN THE DEVICE LOGS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184654 | E SERIES DEFIBRILLATOR | E SERIES | MKJ | ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS | E SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |