BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONESTEP CPR (AP) ELECTRODE

    MDR report key: 3761235 · Received January 2, 2014

    Report

    Report Number
    1220908-2013-03601
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Report Date
    December 18, 2013
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO PLACE THE ELECTRODES ON THE PATIENT, A WIRE HAD BECOME DISLODGED FROM THE ELECTRODE PAD. 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
    1110 ONESTEP CPR (AP) ELECTRODE ELETRODE MLN ZOLL MEDICAL CORPORATION 8900-0213

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK