BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-PADZ LIQUID GEL RADIOLUCENT MFE

    MDR report key: 4905317 · Received July 2, 2015

    Report

    Report Number
    1218058-2015-00039
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Report Date
    June 12, 2015
    Manufacturer
    BIO-DETEK, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 CUSTOMER WAS CONTACTED FOR RETURN OF THE ELECTRODES. THE CUSTOMER INDICATED THAT THE ELECTRODES WILL NOT BE RETURNED TO ZOLL FOR EVALUATION OF THE REPORTED MALFUNCTION. TESTING WAS DONE OF THE RESERVED SAMPLE FROM THE SAME LOT. NO DISCREPANCIES WERE FOUND. THIS COMPLAINT WAS MISTAKENLY REPORTED AND DOES NOT MEET OUR CRITERIA FOR REPORTABILITY.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE AND GENDER UNKNOWN) THE ELECTRODE PADS WOULD NOT ADHERE TO THE PATIENT'S SKIN BEFORE OR AFTER A SHOCK TO THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433296 PRO-PADZ LIQUID GEL RADIOLUCENT MFE ELECTRODES MKJ BIO-DETEK, INC. 8900-2106-01 1615

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK