BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2934744 · Received December 21, 2012

    Report

    Report Number
    3003793491-2012-00523
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE DEVICE ASSOCIATED WITH THIS REPORT. HOWEVER, THE DEVICE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, THE AUTOPULSE PLATFORM WOULD START, BUT STOP AFTER 3-5 COMPRESSIONS. THE PLATFORM WOULD INDICATE "INITIALIZING, LETTERS ON THE SCREEN WOULD FLASH AND DISAPPEAR WHILE THE GREEN BACK-LIGHT WOULD STILL BE LIT, THE PLATFORM WOULD AGAIN INDICATE "INITIALIZING". USER ALSO INDICATED THAT THE PATIENT WAS NOT ADVERSELY AFFECTED. NO ADVERSE EVENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other