BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPR STAT PADZ

    MDR report key: 4266196 · Received October 31, 2014

    Report

    Report Number
    1220908-2014-02787
    Event Type
    Malfunction
    Date Received
    October 31, 2014
    Report Date
    October 14, 2014
    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 CORP 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 TREAT A PATIENT, THE MEDIC WAS UNABLE TO REMOVE THE ELECTRODES FROM THE PACKAGING. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODE PADS TO CONTINUE TREATING 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
    699491 CPR STAT PADZ ELECTRODES MLN ZOLL MEDICAL CORPORATION 8900-0402 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK