BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3161831 · Received May 20, 2013

    Report

    Report Number
    3003793491-2013-00575
    Event Type
    Death
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2013 FOR INVESTIGATION. VISUAL INSPECTION REVEALED NO SIGNIFICANT DISCREPANCIES. REVIEW OF ARCHIVE DATA SHOWED UA 45 AND UA 18 WERE PRESENT. FUNCTIONAL TESTING WAS PERFORMED WITH PASSING RESULTS. CUSTOMER'S REPORTED PROBLEM WAS CONFIRMED DURING INVESTIGATION. THE LIFEBAND STRAPS WERE NOT COMPLETELY PULLED OUT PRIOR TO TURNING ON THE DEVICE. BASED ON THE EVAL RESULTS, A DEFINITIVE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE PLATFORM DISPLAYED USER ADVISORY (UA) 45 ERROR CODE WHILE RESTARTING THE DEVICE DURING A FULL ARREST. THE DEVICE WOULD NOT COMPRESS AFTER THAT. MFR REQUESTED ADDITIONAL INFO ON (B)(4) 2013 AND RECEIVED THE FOLLOWING INFO ON THE SAME DAY: MANUAL CPR WAS INITIATED. THE REPORTED UA 45 COULD NOT BE CLEARED ON THE SCENE. THE AUTOPULSE WAS ABLE TO BE REBOOTED AND RESTARTED WITH NO RECURRING ERRORS. HOWEVER, THE PT WAS PRONOUNCED DEAD IN THE FIELD. THE CAUSE OF DEATH IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221595 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION INC 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death MANUAL CPR