BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODES, ONESTEP COMPLETE

    MDR report key: 4954418 · Received July 24, 2015

    Report

    Report Number
    1218058-2015-00044
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Report Date
    July 7, 2015
    Manufacturer
    BIO-DETEK, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS CONTACTED FOR RETURN OF T HE ELECTRODES. THE CUSTOMER HAS RESPONDED AND INDICATED THE ELECTRODE PADS WERE DISCARDED AND ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE ELECTRODES DO NOT ADHERE TO THE SKIN VERY WELL. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484039 ELECTRODES, ONESTEP COMPLETE ELECTRODE MKJ BIO-DETEK, INC. 8900-0224-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA