FDA Adverse Event
Malfunction
Summary report: N
ONESTEP CPR (AA) ELECTRODES
MDR report key: 3221292
·
Received June 28, 2013
Report
- Report Number
- 1220908-2013-01658
- Event Type
- Malfunction
- Date Received
- June 28, 2013
- Report Date
- June 13, 2013
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MLN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING TRAINING BY FACILITY STAFF, A WIRE HAD BECOME DISLODGED FROM THE ELECTRODE PAD. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295711 | ONESTEP CPR (AA) ELECTRODES | ELECTRODES | MLN | ZOLL MEDICAL CORPORATION | 8900-0217-01 | 12440917 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |