BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4011206 · Received August 14, 2014

    Report

    Report Number
    3010617000-2014-00407
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 THAT THE ENCODER COVER WAS DAMAGED AND THE BATTERY PARTITION COVER WAS MISSING. THE PHYSICAL DAMAGES FOUND DURING VISUAL INSPECTION ARE NOT RELATED TO THE REPORTED COMPLAINT OF INTERMITTENT UA12 (LIFEBAND® NOT PRESENT) FAULTS. THE DAMAGES APPEAR TO HAVE BEEN CAUSED BY NORMAL WEAR AND TEAR (AUTOPULSE MANUFACTURED IN 12/2006). A REVIEW OF THE AUTOPULSE ARCHIVE WAS PERFORMED AND THE REPORTED COMPLAINT WAS CONFIRMED. THE ARCHIVE DATA SHOWS THAT MULTIPLE UA12 FAULTS OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. THE ARCHIVE ALSO SHOWS THAT UA18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) FAULTS OCCURRED ON THE REPORTED EVENT DATE. HOWEVER, THIS USER ADVISORY IS NOT RELATED TO THE REPORTED COMPLAINT. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE PLATFORM WAS RUN FOR 15 MINUTES WITH THE TEST MANNEQUIN AND 7 MINUTES WITH THE LARGE RESUSCITATION TEST FIXTURE (LRTF) AND NO FAULTS WERE OBSERVED DURING COMPRESSIONS. THE PLATFORM WAS ALSO STOPPED AND STARTED AGAIN DURING COMPRESSIONS AND NO PROBLEMS WERE ENCOUNTERED. BASED ON THE INVESTIGATION, THE PARTS IDENTIFIED FOR REPLACEMENT WERE THE ENCODER COVER AND THE BATTERY PARTITION COVER. IN SUMMARY, THE REPORTED COMPLAINT WAS CONFIRMED BASED ON THE ARCHIVE REVIEW BUT COULD NOT BE REPRODUCED DURING FUNCTIONAL TESTING. THE ROOT CAUSE FOR THE UA12 COULD NOT BE DETERMINED. HOWEVER, UA12 IS AN INDICATION THAT THE AUTOPULSE HAS DETECTED THAT THE LIFEBAND IS NOT PROPERLY INSTALLED. THE UA18 OBSERVED IN THE ARCHIVE REVIEW IS UNRELATED TO THE REPORTED COMPLAINT. THE ROOT CAUSE FOR THE UA18 COULD NOT BE DETERMINED. USER ADVISORY 18 IS AN INDICATION THAT THE AUTOPULSE® HAS DETECTED THAT EITHER THE PATIENT'S CHEST IS TOO SMALL WHILE SIZING THE PATIENT (TAKE-UP) OR THAT THERE IS NO PATIENT ON THE PLATFORM. THE PHYSICAL DAMAGES FOUND DURING VISUAL INSPECTION ARE UNRELATED TO THE REPORTED COMPLAINT. UPON REPLACEMENT OF THE ENCODER COVER AND THE BATTERY PARTITION COVER, THE PLATFORM WAS RE-EVALUATED THROUGH FUNCTIONAL TESTING AND THE PLATFORM PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE AUTOPULSE® PLATFORM APPEARED TO WORK FINE, HOWEVER, DURING SHIFT CHANGES A USER ADVISORY (UA) 12 (LIFEBAND® NOT PRESENT) MESSAGE APPEARS WHEN THE PLATFORM IS STOPPED AND STARTED. THE LIFEBAND NEEDS TO BE OPENED AND RESEATED FOR THE PLATFORM TO BEGIN FUNCTIONING AGAIN. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485380 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1