BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODES

    MDR report key: 4594190 · Received March 6, 2015

    Report

    Report Number
    1220908-2015-00514
    Event Type
    Malfunction
    Date Received
    March 6, 2015
    Report Date
    February 16, 2015
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PT (AGE AND GENDER UNK) THE ELECTRODES WOULD NOT ADHERE TO THE PT'S SKIN. COMPLAINANT INDICATED THAT THE CLINICIAN PERFORMED CPR TO CONTINUE TREATING THE PT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH NUMBERS 1220908-2015-00513, 1220908-2015-00505, 1220908-2015-00507, 1220908-2015-00492, 1220908-2015-00522, AND 1220908-2015-00493 FOR SIMILAR REPORTS FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156540 ELECTRODES MULTI-FUNCTION ELECTRODES MKJ ZOLL MEDICAL CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK