BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION MODEL 100

    MDR report key: 4870078 · Received June 25, 2015

    Report

    Report Number
    3010617000-2015-00362
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 3, 2015
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM ((B)(4)) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND THE TOP COVER AND MOTOR COVER WERE OBSERVED TO BE DAMAGED. IT WAS ALSO OBSERVED THAT THE HEAD RESTRAINT BRACKETS WERE CRACKED AND THE BATTERY PARTITION COVER WAS MISSING. FROM THE CONDITION OF THE PLATFORM, THE DAMAGES APPEAR TO HAVE BEEN DUE TO WEAR AND TEAR. FUNCTIONAL TESTING WAS PERFORMED AND IT WAS OBSERVED THAT THE DRIVE SHAFT WAS UNABLE TO ROTATE FREELY. THE CUSTOMER'S REPORTED COMPLAINT OF THE LIFEBAND BEING STIFF AND DIFFICULT TO EXTEND WAS OBSERVED DURING TESTING AND IS ATTRIBUTED TO THE CLUTCH PLATE BEING STICKY. THE STICKY CLUTCH PLATE COULD LEAD TO THE DRIVE SHAFT NOT BEING IN THE "HOME" POSITION, WHICH IN TURN COULD RESULT IN THE PLATFORM DISPLAYING A USER ADVISORY (45). HOWEVER, THE USER ADVISORY (UA) 45 WAS UNABLE TO BE DUPLICATED DURING FUNCTIONAL EVALUATION. A REVIEW OF THE ARCHIVE WAS PERFORMED AND NO USER ADVISORIES OR ERRORS WERE OBSERVED ON THE REPORTED EVENT DATE OF (B)(6) 2015. HOWEVER, MULTIPLE USER ADVISORY 45 ERRORS WERE OBSERVED ON (B)(6) 2015, WHICH WAS THE LAST DATE OF USAGE RECORDED IN THE ARCHIVE. BASED ON THE INVESTIGATION, THE PART(S) IDENTIFIED FOR REPLACEMENT ARE THE TOP COVER, MOTOR COVER, CLUTCH PLATE AND BATTERY PARTITION COVER. IN SUMMARY, THE REPORTED COMPLAINT OF THE PLATFORM DISPLAYING A UA 45 AND THE LIFEBAND BEING DIFFICULT TO EXTEND WAS CONFIRMED THROUGH FUNCTIONAL TESTING AND ARCHIVE REVIEW AND IS ATTRIBUTED TO THE CLUTCH PLATE BEING STICKY. FOLLOWING SERVICE, THE DEVICE PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHIFT CHECK, THE AUTOPULSE PLATFORM CONSTANTLY DISPLAYED A USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) MESSAGE AND THE LIFEBAND IS VERY STIFF AND DIFFICULT TO EXTEND. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412031 AUTOPULSE® RESUSCITATION MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1