BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3913521 · Received July 3, 2014

    Report

    Report Number
    3003793491-2014-00322
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 VISIBLE DAMAGE. A REVIEW OF THE ARCHIVE WAS PERFORMED AND THE REPORTED COMPLAINT OF "ALIGNMENT ERROR" WAS CONFIRMED. THE ARCHIVE DATA SHOWS THAT USER ADVISORIES 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) AND 2 (COMPRESSION TRACKING ERROR) OCCURRED ON (B)(4) 2014 RATHER THAN ON THE REPORTED EVENT DATE OF (B)(4) 2014. A USER ADVISORY 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION) WAS ALSO OBSERVED ON THE (B)(4) 2014, HOWEVER, THIS IS UNRELATED TO THE REPORTED COMPLAINT. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE OF "ALIGNMENT ERROR" COULD NOT BE REPRODUCED. THE PLATFORM WAS RUN FOR 5 MINUTES WITH A TEST MANIKIN USING THE CUSTOMER'S LIFEBAND AND NO PROBLEMS WERE FOUND. IN ADDITION, THE PLATFORM WAS ALSO RAN FOR 5 MINUTES WITH THE LRTF (LARGE RESUSCITATION TEST FIXTURE) WHICH IS EQUIVALENT TO 250 POUNDS AND NO PROBLEMS WERE OBSERVED. IN SUMMARY, THE REPORTED COMPLAINT OF "ALIGNMENT ERROR" OCCURRING WAS CONFIRMED BASED ON THE ARCHIVE REVIEW BUT COULD NOT BE REPRODUCED DURING FUNCTIONAL TESTING. THE ROOT CAUSE FOR UA7, UA17 AND UA2 COULD NOT BE DETERMINED. HOWEVER, PER THE BATTERY HANGTAG - ADVISORY CODES DESCRIPTION AND ACTION (PN 12741-001), USER ADVISORY 7 IS AN INDICATION THAT THE PATIENT IS OUT OF POSITION, THE PATIENT IS NOT PROPERLY CENTERED. 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. 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.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING PATIENT USE, THE AUTOPULSE® PLATFORM WAS EXPERIENCING ALIGNMENT ISSUES. THE EXACT ERROR CODE WAS NOT RECORDED. THE PATIENT WAS RE-POSITIONED, HOWEVER THE "ALIGNMENT ERROR" CONTINUED TO PERSIST AND THE DEVICE WAS UNABLE TO DELIVER THERAPY. CUSTOMER REVERTED TO MANUAL CPR (EXACT LENGTH OF TIME WAS NOT PROVIDED). CUSTOMER WAS UNABLE TO PROVIDE ANY PATIENT INFORMATION AND IS UNAWARE OF ANY ADVERSE EFFECTS TO THE PATIENT. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390714 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 MANUAL CPR