FDA Adverse Event
Malfunction
Summary report: N
ONE STEP COMPLETE ELECTRODE
MDR report key: 3101358
·
Received April 29, 2013
Report
- Report Number
- 1220908-2013-01164
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Report Date
- April 11, 2013
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MLN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- 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 DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ASSOCIATED DEFIBRILLATOR FAILED SELF-TEST WITH THESE ELECTRODE ATTACHED. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184700 | ONE STEP COMPLETE ELECTRODE | ELECTRODE | MLN | ZOLL MEDICAL CORPORATION | 8900-0214 | 4911 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |