FDA Adverse Event
Malfunction
Summary report: N
E SERIES DEFIBRILLATOR
MDR report key: 1190668
·
Received October 3, 2008
Report
- Report Number
- 1220908-2008-02413
- Event Type
- Malfunction
- Date Received
- October 3, 2008
- Report Date
- September 29, 2008
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "PACER FAULT 111" AND "DEFIB FAULT 72" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | E SERIES DEFIBRILLATOR | E SERIES | MKJ | ZOLL MEDICAL CORPORATION | E SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |