BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLID GEL MFE, ADULT

    MDR report key: 1064551 · Received June 20, 2008

    Report

    Report Number
    1220908-2008-01265
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 29, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS RECEIVED THE PRODUCT, AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PT, ARCING WAS OBSERVED FROM THE ELECTRODE PAD. COMPLAINANT INDICATED THAT ONE OF THE ELECTRODES WAS PLACED ON TOP OF A SURGICAL DRAPE. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLID GEL MFE, ADULT DEFIB/PACING ELECTRODE MLN ZOLL MEDICAL CORPORATION 8900-4000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death