BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-FUNCTION ELECTRODES

    MDR report key: 4594194 · Received March 6, 2015

    Report

    Report Number
    1220908-2015-00522
    Event Type
    Malfunction
    Date Received
    March 6, 2015
    Date of Event
    January 26, 2015
    Report Date
    February 17, 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

    COMPLAINT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A MALE PT IN CARDIAC ARREST (AGE UNK), THE ELECTRODES WOULD NOT ADHERE TO THE PT'S SKIN. COMPLAINANT INDICATED THAT THE PT WAS BEING TREATED WITH AN AUTOPULSE AND AED DEVICE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH NUMBERS 1220908-2015-00514, 1220908-2015-00513, 1220908-2015-00505, 1220908-2015-00507, 1220908-2015-00492, AND 1220908-2015-00493 FOR SIMILAR REPORTS FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156313 MULTI-FUNCTION ELECTRODES MULTI-FUNCTION ELECTRODES MKJ ZOLL MEDICAL CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK