BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3885110 · Received June 19, 2014

    Report

    Report Number
    3003793491-2014-00286
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON 06/02/2014 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS THAT THE BATTERY LOCK WAS BENT. THE PHYSICAL DAMAGE FOUND DURING VISUAL INSPECTION IS NOT RELATED TO THE REPORTED COMPLAINT. THE DAMAGE APPEARS TO HAVE BEEN CAUSED BY NORMAL WEAR AND TEAR (AUTOPULSE MANUFACTURED IN SEPTEMBER OF 2009). A REVIEW OF THE ARCHIVE WAS PERFORMED AND THE REPORTED COMPLAINT OF A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE DISPLAYED ON THE PLATFORM AFTER TWO MINUTES AND THE PLATFORM SHUTTING DOWN WAS CONFIRMED. THE ARCHIVE DATA SHOWS THAT TWO SESSIONS OF TWO MINUTE TIME OUT'S OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE OF A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE WAS VERIFIED. UPON POWER UP OF THE PLATFORM, THE "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" (ERROR CODE 203) MESSAGE WAS OBSERVED. THE ERROR WAS CLEARED AND THE PLATFORM RAN FOR 15 MINUTES WITH NO PROBLEMS OBSERVED. BASED ON THE INVESTIGATION, THE PART IDENTIFIED FOR REPLACEMENT IS THE BATTERY LOCK. IN SUMMARY, THE REPORTED COMPLAINT OF A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE DISPLAYED ON THE PLATFORM AFTER TWO MINUTES AND THE PLATFORM SHUTTING DOWN WAS CONFIRMED BASED ON THE ARCHIVE REVIEW. THE SYSTEM ERROR MESSAGE WAS ALSO VERIFIED DURING FUNCTIONAL TESTING. THE ERROR MESSAGE WAS CLEARED AND THE PLATFORM PASSED FUNCTIONAL TEST. THE PHYSICAL DAMAGE FOUND DURING VISUAL INSPECTION IS UNRELATED TO THE REPORTED COMPLAINT. UPON REPLACEMENT OF THE BATTERY LOCK AND CLEARING THE ERROR MESSAGE, THE PLATFORM PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHIFT CHECK, THE AUTOPULSE PLATFORM DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE. CALLER STATED THAT THE FAN CAME ON, BUT THE LIFEBAND DID NOT RETRACT WHEN THE GREEN "START" BUTTON WAS PRESSED. THE PLATFORM DID NOT RESPOND AND DISPLAYED THE "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE AFTER TWO MINUTES, THEN POWERED OFF. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361285 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1