FDA Adverse Event
Malfunction
Summary report: N
ONE STEP COMPLETE ELECTRODE
MDR report key: 4737633
·
Received April 24, 2015
Report
- Report Number
- 1218058-2015-00006
- Event Type
- Malfunction
- Date Received
- April 24, 2015
- Report Date
- April 6, 2015
- Manufacturer
- BIO-DETEK, INC.
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS REC'D THE PROD AND WILL BE PROVIDING A F/U REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ELECTRODES CAUSED THE ASSOCIATED DEFIBRILLATOR TO DISPLAY A "CHECK PADS" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT TO THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271686 | ONE STEP COMPLETE ELECTRODE | ELECTRODE | MKJ | BIO-DETEK, INC. | 8900-0214 | 3713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |