BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4141252 · Received October 3, 2014

    Report

    Report Number
    3010617000-2014-00502
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IN COMPLAINT WAS RETURNED TO ZOLL ON (B)(4) 2014 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND THE FRONT ENCLOSURE WAS FOUND TO BE DAMAGED. FROM THE CONDITION OF THE RETURNED PLATFORM, THE DAMAGE APPEARS TO HAVE BEEN DUE TO WEAR AND TEAR. THE SYSTEM ERROR - ERROR CODE 132 (INTERNAL WATCHDOG TIMEOUT) WAS OBSERVED DURING FUNCTIONAL TESTING. THE ERROR WAS CLEARED. AFTER THE FAULT WAS CLEARED, THE PLATFORM WAS RUN WITH A LRTF (LARGE RESUSCITATION TEST FIXTURE) FOR 15 MINUTES WITH NO PROBLEMS ENCOUNTERED. A REVIEW OF THE ARCHIVE WAS PERFORMED AND THE REPORTED COMPLAINT OF THE PLATFORM DISPLAYING AN ERROR 132 WAS CONFIRMED TO HAVE OCCURRED ON (B)(6) 2014. NO USER ADVISORIES (UAS) OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. BASED ON THE INVESTIGATION, THE PART IDENTIFIED FOR REPLACEMENT WAS THE FRONT ENCLOSURE. IN SUMMARY, THE REPORTED COMPLAINT OF THE PLATFORM DISPLAYING A SYSTEM ERROR 132 WAS CONFIRMED DURING FUNCTIONAL EVALUATION AS WELL AS THROUGH ARCHIVE REVIEW. THE ERROR WAS CLEARED. FOLLOWING CLEARING THE ERROR 132 AND REPLACEMENT OF THE DAMAGED FRONT ENCLOSURE, THE PLATFORM PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A SHIFT CHECK THE AUTOPULSE® PLATFORM DISPLAYED A "SYSTEM ERROR". THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620375 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1