BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES

    MDR report key: 4841809 · Received June 8, 2015

    Report

    Report Number
    1218058-2015-00020
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Report Date
    May 19, 2015
    Manufacturer
    BIO-DETEK, INC.
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 A ROUTINE SHIFT CHECK BY A CLINICIAN, THE ELECTRODES CAUSED THE DEVICE 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
    369547 ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES ELECTRODE DRX BIO-DETEK, INC. 8900-0224-01 1315C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA