BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPR STAT PADZ

    MDR report key: 1170373 · Received September 10, 2008

    Report

    Report Number
    1220908-2008-02115
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 25, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT, AN ARC WAS SEEN FROM THE ELECTRODES PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. THE CUSTOMER HAS INDICATED THAT THE EVENT ELECTRODE PADS WERE DISCARDED AND THEY ARE NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPR STAT PADZ ELECTRODE MLN ZOLL MEDICAL CORPORATION 8900-0400 1208

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK