BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODES, MFE, STAT-PADZ II

    MDR report key: 1051246 · Received May 22, 2008

    Report

    Report Number
    1220908-2008-01130
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Report Date
    May 6, 2008
    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 RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED. THIS IS THE FIRST OF TWO SETS OF STAT PADS THE SECOND SET REPORTED UNDER MEDWATCH NUMBER 1220908-2008-01131.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING TRAINING BY FACILITY STAFF, THE ASSOCIATED DEFIBRILLATOR WAS UNABLE TO DETECT THE ATTACHED DEVICE. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRODES, MFE, STAT-PADZ II DEFIB/PACING ELECTRODES MLN ZOLL MEDICAL CORPORATION 8900-0801 1308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA