FDA Adverse Event
Malfunction
Summary report: N
ONESTEP CPR (AA) ELECTRODES
MDR report key: 2911292
·
Received December 11, 2012
Report
- Report Number
- 1220908-2012-03330
- Event Type
- Malfunction
- Date Received
- December 11, 2012
- Report Date
- November 26, 2012
- Manufacturer
- ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
- Product Code
- MKJ
- PMA / PMN Number
- K060559
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS NOT RECEIVED THE PRODUCT FOR EVAL AND THIS THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ELECTRODE WIRES PULLED APART FROM THE ELECTRODE. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONESTEP CPR (AA) ELECTRODES | ELECTRODE | MKJ | ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS | 8900-0217-01 | 4311 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |