BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2860648 · Received October 29, 2012

    Report

    Report Number
    3003793491-2012-00210
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    August 10, 2012
    Report Date
    August 10, 2012
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF "UNABLE TO RESET AND SIZE DOWN THE PT" WAS NOT VERIFIED. AUTOPULSE WAS TESTED WITH A TEST MANIKIN FOR MORE THAN 20 MINUTES, AND WAS TESTED WITH LRTF (LARGE RESUSCITATION TEST FIXTURE) FOR 5 MINUTES WITHOUT ANY PROBLEM. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PT CARE 4 OR 5 ATTEMPTS TO RESET AND SIZE DOWN THE PT IN ORDER FOR THE SYSTEM TO WORK WERE MADE. 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 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other