BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES

    MDR report key: 4746369 · Received April 29, 2015

    Report

    Report Number
    1218058-2015-00013
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Report Date
    April 9, 2015
    Manufacturer
    BIO-DETEK INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT RECEIVED THE PRODUCT FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PT (AGE AND GENDER UNK), THE ASSOCIATED DEVICE DISPLAYED "CHECK PADS" AND "POOR PAD CONTACT" MESSAGES USING THESE ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN PRESSED DOWN ON THE ELECTRODES TO THE PATIENTS SKIN TO CONTINUE TREATMENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282548 ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES ELECTRODE MKJ BIO-DETEK INC. 8900-0224-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK