FDA Adverse Event
Malfunction
Summary report: N
ONESTEP CPR (AP) ELECTRODE
MDR report key: 3063036
·
Received March 27, 2013
Report
- Report Number
- 1220908-2013-00688
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Report Date
- March 6, 2013
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MLN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- 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 BIOMED TESTING, THE WIRES WERE DISLODGED 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 |
|---|---|---|---|---|---|---|---|
| 125161 | ONESTEP CPR (AP) ELECTRODE | ELECTRODE | MLN | ZOLL MEDICAL CORPORATION | 8900-0213 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |