FDA Adverse Event
Malfunction
Summary report: N
ONE STEP COMPLETE ELECTRODE, 8 PER CASE
MDR report key: 2050422
·
Received April 4, 2011
Report
- Report Number
- 1220908-2011-00865
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Report Date
- March 16, 2011
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MLN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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 ELECTRODES CAUSED THE ASSOCIATED DEFIBRILLATOR TO FAIL SELF-TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE STEP COMPLETE ELECTRODE, 8 PER CASE | ELECTRODE | MLN | ZOLL MEDICAL CORPORATION | 8900-0214 | 2310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |