BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2870424 · Received November 13, 2012

    Report

    Report Number
    3003793491-2012-00147
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 4, 2012
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) INVOLVED IN THE EVENT WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2012 AND WAS ANALYZED. VISUAL INSPECTION OF THE PLATFORM REVEALED A DAMAGED LCD. THE LCD WAS REPLACED. THE ARCHIVE DATA WAS CORRUPTED THEREFORE UNABLE TO DOWNLOAD ANY DATA. WHEN POWERING UP THE DEVICE, LATCH ERROR 132 (INTERNAL WATCHDOG TIMEOUT) WAS SEEN. THE PROCESSOR PCA BOARD WAS FOUND DEFECTIVE SO IT WAS REPLACED. THE PLATFORM PASSED FINAL TEST. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    DEVICE WAS CONTAMINATED FROM USE. THE MEMBERS WASHED THE BOARD DOWN WITH A GARDEN HOSE. THE DEVICE POWERS UP TO "UNIT OUT OF SERVICE". THIS "UNIT OUT OF SERVICE" ERROR MESSAGE WAS SEEN AFTER THE BOARD WAS DRIED OFF BUT NOT SURE FOR HOW LONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other