FDA Adverse Event
Malfunction
Summary report: N
ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES
MDR report key: 4875279
·
Received June 23, 2015
Report
- Report Number
- 1218058-2015-00029
- Event Type
- Malfunction
- Date Received
- June 23, 2015
- Report Date
- June 3, 2015
- Manufacturer
- BIO-DETEK, INC.
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION EVALUATED THE ELECTRODES AND THE REPORTED MALFUNCTION WAS NOT REPLICATED OR CONFIRMED. THE ELECTRODES WERE PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE MALFUNCTION. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.
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 A ROUTINE SHIFT CHECK BY A CLINICIAN, THESE ELECTRODES CAUSED THE ASSOCIATED DEVICE TO FAIL SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 404716 | ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES | ELECTRODE | MKJ | BIO-DETEK, INC. | 8900-0224-01 | 1015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |