BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARINA

    MDR report key: 5301918 · Received December 16, 2015

    Report

    Report Number
    9611500-2015-00293
    Event Type
    Malfunction
    Date Received
    December 16, 2015
    Date of Event
    November 29, 2015
    Report Date
    January 29, 2016
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    PMA / PMN Number
    K072885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOTOR- AND BLOWER-ASSEMBLY OF THE DEVICE HAS BEEN REPLACED AND SENT IN FOR INVESTIGATION. THE DEVICE LOG WAS DOWNLOADED AND MADE AVAILABLE FOR INVESTIGATION. THE LOG ANALYSIS SHOWED THAT SEVERAL ALARMS "BLOWER DEFECT" AND "BLOWER POST FAIL" HAVE BEEN REGISTERED IN THE LAST MONTH. THESE ERROR ENTRIES ARE REGISTERED IF THE BLOWER ROTATION SPEED DIFFERS FROM THE EXPECTED VALUES. "BLOWER DEFECT" IS POSTED IF THIS HAPPENS DURING USE AND "BLOWER POST FAIL" IF THE DEVIATION OCCURS DURING START-UP AND SELFTEST. THE RETURNED MOTOR- AND BLOWER-ASSEMBLY WAS OPERATED IN A CARINA TEST DEVICE FOR 150 HOURS TO REPRODUCE THE OBSERVED DEVIATION, BUT IT SHOWED NO MALFUNCTION. FURTHERMORE THIS TEST-CARINA WAS NEWLY STARTED MORE THAN 50 TIMES WITHOUT ANY UNACCEPTABLE TURBINE ROTATION SPEED DEVIATIONS DURING DEVICE START AND PRE USE CHECK. THEREFORE THE ROOT CAUSE COULD NOT BE IDENTIFIED. IN CASE OF THE REGISTERED ALARMS THE BLOWER WILL BE STOPPED TO PREVENT FROM FURTHER DEVIATION AND THE HIGH PRIORITY ALARM "DEVICE FAILURE !!!" WILL BE GIVEN. THE EMERGENCY BREATHING VALVE WILL BE OPENED AUTOMATICALLY TO ALLOW SPONTANEOUS BREATHING OF THE PATIENT. THIS IS THE SPECIFIED BEHAVIOR FOR THE GIVEN CONDITIONS. VENTILATION OF THE PATIENT WITH AN INDEPENDENT VENTILATION DEVICE MAY BE NECESSARY. AFTER THE "DEVICE FAILURE !!!" ALARM HAD BEEN POSTED, THE DEVICE SHOULD NO LONGER HAVE BEEN USED ON PATIENT WITHOUT DIAGNOSIS AND REPAIR. AS MALFUNCTION OF THE MOTOR- AND BLOWER-ASSEMBLY COULD NOT BE VERIFIED, FURTHER COMPONENTS OF THE DEVICE SHOULD BE CHECKED OR REPLACED. CORRESPONDING RECOMMENDATIONS HAVE BEEN GIVEN.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS STARTED BUT IS NOT YET CONCLUDED. THE INVESTIGATION RESULT WILL BE REPORTED IN A FOLLOW UP-REPORT.

    Description of Event or Problem · 1

    PLEASE SEE INITIAL-REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE ON PATIENT THE DEVICE ALARMED A DEVICE FAILURE. THE DEVICE WAS REPORTINGLY NOT ABLE TO DELIVER FLOW. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832329 CARINA VENTILATORS, OTHER CBK DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1