BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3962205 · Received July 28, 2014

    Report

    Report Number
    3003793491-2014-00377
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL CIRCULATION HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS NO PHYSICAL DAMAGE, BESIDES MINOR SCRATCHES OBSERVED ON THE BOTTOM OF THE PLATFORM. IT WAS ALSO OBSERVED THAT THE LIFEBAND CLIPPED INTO THE AUTOPULSE WITH NO ISSUES AND ROTATED FREELY. THE MINOR SCRATCHES OBSERVED DURING VISUAL INSPECTION ARE NOT RELATED TO THE REPORTED COMPLAINT. THE DAMAGES APPEAR TO HAVE BEEN CAUSED BY NORMAL WEAR AND TEAR (AUTOPULSE MANUFACTURED IN 8/2009). A REVIEW OF THE AUTOPULSE ARCHIVE WAS PERFORMED AND REPORTED COMPLAINT OF UA12 FAULTS WAS NOT CONFIRMED. THE ARCHIVE DATA SHOWS NO INSTANCES OF UA12 FAULTS OCCURRING. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE PLATFORM FUNCTIONED AS INTENDED. THE AUTOPULSE DETECTED THE LIFEBAND WITH NO ISSUES. THE PLATFORM WAS TESTED WITH A LIFEBAND AND WAS ABLE TO TAKE UP THE LIFEBAND AND PERFORM COMPRESSIONS ON A MANNEQUIN. NO USER ADVISORIES WERE OBSERVED. DURING TESTING, IT WAS OBSERVED THAT THE UI MEMBRANE WAS NOT FUNCTIONING PROPERLY. HOWEVER, THIS IS UNRELATED TO THE REPORTED COMPLAINT. BASED ON THE INVESTIGATION, THE PART IDENTIFIED FOR REPLACEMENT WAS THE UI MEMBRANE. IN SUMMARY, THE REPORTED COMPLAINT OF UA12 FAULTS WAS NOT CONFIRMED BASED ON THE ARCHIVE REVIEW AND COULD NOT BE REPRODUCED DURING FUNCTIONAL TESTING. THE PHYSICAL DAMAGE FOUND DURING VISUAL INSPECTION IS UNRELATED TO THE REPORTED COMPLAINT. UPON REPLACEMENT OF THE UI MEMBRANE, THE PLATFORM WAS RE-EVALUATED THROUGH FUNCTIONAL TESTING AND THE PLATFORM PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT EVEN THOUGH THE AUTOPULSE LIFEBAND WAS PROPERLY INSTALLED AND WAS ABLE TO ROTATE FREELY, THE AUTOPULSE PLATFORM KEPT DISPLAYING A USER ADVISORY (UA) 12 (LIFEBAND® NOT PRESENT) MESSAGE. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. PLEASE NOTE THAT THE EVENT DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439304 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 AUTOPULSE® LIFEBAND,CHEST COMPRESSION ASSEMBLY