BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3771599 · Received April 24, 2014

    Report

    Report Number
    3003793491-2014-00215
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 2, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND THE FOLLOWING WAS OBSERVED: THE MOTOR COVER, BATTERY COMPARTMENT AND ENCODER COVER WERE DAMAGED. THE BATTERY PARTITION COVER WAS ALSO FOUND TO BE MISSING. FROM THE CONDITION OF THE RETURNED UNIT, THE DAMAGES APPEARED TO BE DUE TO NORMAL WEAR AND TEAR. DURING POWER ON OF THE PLATFORM, A UA 41 FAULT (PATIENT TEMPERATURE SENSOR FAILED) WAS DISPLAYED. FURTHER TESTING DETERMINED THAT FAULT WAS DUE TO A DEFECTIVE TEMPERATURE SENSOR. A REVIEW OF THE ARCHIVE WAS PERFORMED AND NO FAULTS WERE FOUND TO HAVE OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. THE ARCHIVE DATA DID HOWEVER SHOW UA 41 FAULTS OCCURRING ON THE LAST SESSION DATE OF (B)(6) 2014. IN SUMMARY, THE REPORTED COMPLAINT WAS CONFIRMED DURING FUNCTIONAL TESTING AS WELL AS ARCHIVE REVIEW AND FOUND TO BE DUE TO A DEFECTIVE PATIENT TEMPERATURE SENSOR.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE AUTOPULSE PLATFORM DISPLAYED A USER ADVISORY (UA) 41 (PATIENT TEMPERATURE SENSOR FAILURE) MESSAGE. COMPLAINANT ALSO REPORTED THAT THE LIFEBAND WAS FULLY EXTENDED AND A FULL WEIGHT MANNEQUIN WAS PLACED ON THE PLATFORM, IN AN EFFORT TO CLEAR THE USER ADVISORY. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249857 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1