BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3816979 · Received May 19, 2014

    Report

    Report Number
    3003793491-2014-00251
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 27, 2014
    Report Date
    April 28, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED TO MANUFACTURER FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS NO PHYSICAL DAMAGE TO THE PLATFORM. A REVIEW OF THE ARCHIVE WAS PERFORMED AND THE REPORTED COMPLAINT OF "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE WAS CONFIRMED. THE ARCHIVE DATA SHOWS THAT SYSTEM ERROR 139 (UNABLE TO HOLD COMPRESSION POSITION) OCCURRED ON (B)(6) 2014, RATHER THAN ON THE REPORTED EVENT DATE OF (B)(6) 2014. THE ARCHIVE ALSO SHOWS THAT NO SESSIONS OCCURRED ON (B)(6) 2014. FURTHERMORE, THE ARCHIVE ALSO SHOWS THAT USER ADVISORY (UA) 2 (COMPRESSION TRACKING ERROR) AND USER ADVISORY (UA) 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION) OCCURRED ON (B)(6) 2014. HOWEVER, THE UA2 AND UA17 ARE NOT RELATED TO THE REPORTED COMPLAINT. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE OF A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE WAS REPRODUCED. DURING TESTING, THE ERROR MESSAGE WAS OBSERVED ON THE AUTOPULSE PLATFORM SCREEN. THE ERROR CODE WAS CLEARED IN THE SYSTEM. BASED ON THE INVESTIGATION, NO PART WAS IDENTIFIED FOR REPLACEMENT. IN SUMMARY, THE REPORTED COMPLAINT OF A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" ERROR MESSAGE WAS CONFIRMED BASED ON THE ARCHIVE REVIEW AND DURING FUNCTIONAL TESTING. THE FAULT WAS CLEARED IN THE SYSTEM. A ROOT CAUSE FOR THE "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE COULD NOT BE DETERMINED. THE UA2 AND UA17 OBSERVED DURING THE ARCHIVE REVIEW ARE UNRELATED TO THE REPORTED COMPLAINT. THE ROOT CAUSE FOR THESE USER ADVISORIES ARE UNABLE TO BE DETERMINED. HOWEVER, PER THE BATTERY HANGTAG - ADVISORY CODES DESCRIPTION AND ACTION (PN 12741-001), USER ADVISORY 2 IS AN INDICATION THAT THE AUTOPULSE HAS DETECTED A CHANGE IN LIFEBAND TENSION. THIS ADVISORY CAN HAPPEN WHEN THE PATIENT OR LIFEBAND IS OUT OF POSITION, OR IF THE LIFEBAND IS OPENED DURING ACTIVE OPERATION. PER THE BATTERY HANGTAG - ADVISORY CODES DESCRIPTION AND ACTION (PN 12741-001), USER ADVISORY 17 IS AN INDICATION THAT THE LIFEBAND IS TWISTED OR BATTERY VOLTAGE IS LOW. UPON CLEARING THE ERROR CODE, THE PLATFORM PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING PATIENT USE, THE AUTOPULSE PLATFORM DISPLAYED A "SYSTEM ERROR-OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE, AFTER THREE OR FOUR COMPRESSIONS WERE PERFORMED. COMPLAINANT ALSO REPORTED THAT MANUAL CPR (LENGTH OF TIME NOT PROVIDED) WAS PERFORMED DURING TRANSPORT TO THE HOSPITAL AND WHEN THE FIRE DEPARTMENT LEFT THE HOSPITAL, THE PATIENT WAS ALIVE. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296915 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 MANUAL CPR