BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4433836 · Received January 20, 2015

    Report

    Report Number
    3010617000-2015-00051
    Event Type
    Malfunction
    Date Received
    January 20, 2015
    Date of Event
    December 22, 2014
    Report Date
    December 29, 2014
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND FOUND THAT THE TOP ENCLOSURE HAD A MISSING SCREW, THE BOTTOM COVER, TOP COVER AND BATTERY COMPARTMENT ARE DAMAGED AND THE BATTERY LOCK PIN IS BROKEN. THE PLATFORM WAS TURNED ON/OFF WITH NO PROBLEMS AND RUN FOR 15 MINUTES USING A TEST MANNEQUIN AND AN ADDITIONAL 30 MINUTES WITH THE LARGE RESUSCITATION TEST FIXTURE (EQUIVALENT TO 250 POUND PATIENT) WITH NO PROBLEMS OR ERRORS. A REVIEW OF THE ARCHIVE WAS PERFORMED WHICH FOUND THAT USER ADVISORY (UA) 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) AND UA2 (COMPRESSION TRACKING ERROR) MESSAGES OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. PER THE AUTOPULSE TECHNICAL SERVICE GUIDE (P/N 11377-006) UA2 IS EXHIBITED WHEN THE AUTOPULSE® HAS DETECTED A CHANGE IN LIFEBAND® TENSION. THIS ADVISORY OCCURS WHEN THE PATIENT OR LIFEBAND® IS OUT OF POSITION, OR THE LIFEBAND® IS OPENED DURING ACTIVE OPERATION. NO PARTS NEED TO BE REPLACED TO REMEDY THE UA18. IN SUMMARY THE CUSTOMER'S REPORTED COMPLAINT OF THE PLATFORM EXHIBITING A UA18 WAS CONFIRMED THROUGH REVIEW OF THE ARCHIVE. THE ROOT CAUSE WAS DETERMINED TO HAVE BEEN CAUSED BY NO LOAD BEING PLACED ON THE PLATFORM.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A SHIFT CHECK, THE AUTOPULSE® PLATFORM DISPLAYED A USER ADVISORY (UA) 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED) MESSAGE THAT WAS UNABLE TO BE CLEARED. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47240 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1