FDA Adverse Event
Malfunction
Summary report: N
E-SERIES DEFIBRILLATOR
MDR report key: 1172720
·
Received September 19, 2008
Report
- Report Number
- 1220908-2008-02233
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Report Date
- September 8, 2008
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT THE DEVICE DISPLAYED A "DEFIB FAULT 111" MESSAGE. 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 |
|---|---|---|---|---|---|---|---|
| 1 | E-SERIES DEFIBRILLATOR | E SERIES | MKJ | ZOLL MEDICAL CORPORATION | E SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |