FDA Adverse Event
Malfunction
Summary report: N
E SERIES DEFIBRILLATOR
MDR report key: 1905641
·
Received November 12, 2010
Report
- Report Number
- 1220908-2010-03304
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Report Date
- October 21, 2010
- 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 ATTACHING THE ECG CABLE TO THE ECG CONNECTOR ON THE BACK OF THE DEVICE, THE CLINICIAN RECEIVED AN UNINTENDED DELIVERY OF ENERGY. THE COMPLAINANT INDICATED THAT THE DEVICE HAD BEEN SHUT OFF AND WAS SITTING IN THE BACK OF THE AMBULANCE AT THE TIME OF THE REPORTED MALFUNCTION. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE CLINICIAN DUE TO 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 | UNK |