BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE? RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3191522 · Received June 26, 2013

    Report

    Report Number
    3003793491-2013-00700
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL CIRCULATION ON 06/06/2013 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: UA02(COMPRESSION TRACKING ERROR) FAULT WAS OBSERVED IN THE ARCHIVE BUT THE FAULT COULD NOT BE VERIFIED DURING TESTING. THE RETURNED PLATFORM RAN WITH THE MANIKIN AND THE LARGE RESUSCITATION TEST FIXTURE WITH NO PROBLEMS. IT WAS NOTICED THAT THE UA02 OCCURRED DURING SHIFT CHECK. THE UA02 TYPICALLY OCCURS IF PATIENT IS MISALIGNED ON THE AUTOPULSE OR THE LIFEBAND IS OPENED. THE PLATFORM PASSED FINAL TEST. PROBABLE CAUSE OF REPORTED FAILURE COULD BE DUE TO USER ERROR. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON SHIFT CHECK, THE USER FOUND THAT THE AUTOPULSE PLATFORM DISPLAYED "USER ADVISORY 2" (COMPRESSION TRACKING ERROR) MESSAGE THAT COULD NOT BE CLEARED. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290081 AUTOPULSE? RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1