BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3930446 · Received July 11, 2014

    Report

    Report Number
    3003793491-2014-00335
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND NO DAMAGES WERE NOTED. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE OF A UA 45 FAULT (NOT AT "HOME" POSITION AFTER POWER-ON/RE-START) WAS REPRODUCED. FURTHER INSPECTION DETERMINED THAT THE CAUSE OF THIS FAULT WAS THAT THE DRIVESHAFT WAS OUT OF ITS HOME POSITION. FOLLOWING RE-POSITIONING OF THE DRIVESHAFT, THE AUTOPULSE PLATFORM PASSED FUNCTIONAL TESTING USING A TEST MANNEQUIN AS WELL AS A LRTF - LARGE RESUSCITATION TEST FIXTURE (EQUIVALENT TO (B)(6) POUND PATIENT). A REVIEW OF THE ARCHIVE WAS PERFORMED AND THE REPORTED COMPLAINT THAT THE PLATFORM DISPLAYED A USER ADVISORY 45 FAULT ON (B)(4) 2014 WAS CONFIRMED. THE ARCHIVE ALSO SHOWS THAT A USER ADVISORY 20 (POSITION OUT OF RANGE) MESSAGE OCCURRED ON THE SAME DATE. A POSSIBLE CAUSE FOR THE UA 20 COULD BE THAT THE USER DID NOT FULLY EXTEND THE LIFEBAND PRIOR TO CYCLING THE PLATFORM ON. BASED ON THE EVALUATION, A CAUSE FOR THE UA 20 COULD NOT BE DETERMINED. BASED ON THE INITIAL INVESTIGATION, THERE WERE NO PARTS IDENTIFIED FOR REPLACEMENT IN ORDER TO REMEDY THE COMPLAINT. IN SUMMARY, THE REPORTED COMPLAINT OF A UA 45 FAULT OCCURRING WAS CONFIRMED BASED ON FUNCTIONAL EVALUATION AS WELL AS THROUGH ARCHIVE REVIEW. THE UA 45 FAULT WAS FOUND TO BE DUE TO THE DRIVESHAFT BEING OUT OF ITS HOME POSITION. ARCHIVE DATA ALSO SHOWED THAT A UA 20 FAULT OCCURRED ON THE REPORTED EVENT. A CAUSE FOR THE UA 20 COULD NOT BE DETERMINED. AFTER THE DRIVESHAFT WAS ADJUSTED BACK TO ITS INTENDED POSITION, THE UA 45 FAULT WAS CLEARED AND THE DEVICE PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE AUTOPULSE® UNIT WAS DISPLAYING A USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) MESSAGE. IN AN EFFORT TO TROUBLESHOOT THE PROBLEM, THE CUSTOMER ATTEMPTED TO SET THE DRIVESHAFT BACK TO THE "HOME" POSITION BY ROTATING IT AND UTILIZING THE ADMINISTRATIVE MENU. CUSTOMER ALSO ATTEMPTED TO USE A NEW LIFEBAND AND FULLY CHARGED BATTERY, HOWEVER, THE ISSUE CONTINUED TO PERSIST. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408117 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSIONS DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1