BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE¿ RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3191753 · Received June 26, 2013

    Report

    Report Number
    3003793491-2013-00716
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND CONFIRMED THE ENCODER COVER WAS CRACKED. A DEFINITIVE CAUSE FOR THIS DAMAGE COULD NOT BE CONFIRMED. DURING VISUAL INSPECTION, IT WAS ALSO DETECTED THAT THE LIFEBAND WILL FALL OFF ONLY WHEN THE DEVICE WAS FLIPPED OVER AND SHAKEN WITH A LOT OF FORCE. BASED ON THIS OBSERVATION, THE REPORTED COMPLAINT WAS CONFIRMED. A REVIEW OF THE ARCHIVE WAS PERFORMED AND NO SIGNIFICANT DISCREPANCIES WERE NOTED. FUNCTIONAL TESTING OF THE PLATFORM WAS PERFORMED AND NO ISSUES WERE NOTED. IN SUMMARY, THE REPORTED ISSUE OF THE LIFEBAND NOT LOCKING FIRMLY ONTO THE PLATFORM WAS CONFIRMED, HOWEVER A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ZOLL CIRCULATION HAS RECEIVED THE PRODUCT IN COMPLAINT AND A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE RESUSCITATION SYSTEM EXPERIENCED MULTIPLE FAILURES, HOWEVER THE FAILURES OBSERVED HAVE BEEN INTERMITTENT. CUSTOMER ALSO INDICATED THAT THE CLIPS OF THE LIFEBAND ON BACK OF THE BOARD WERE NOT CLIPPING IN AND COME OFF VERY EASILY. NO ADVERSE PATIENT SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291387 AUTOPULSE¿ RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1