BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARINA

    MDR report key: 5610960 · Received April 27, 2016

    Report

    Report Number
    9611500-2016-00106
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    March 27, 2016
    Report Date
    May 19, 2016
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    PMA / PMN Number
    K072885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ERROR CODE ¿00.A008¿ IS POSTED IF THE ROTATION SPEED OF THE BLOWER DIFFERS FROM THE EXPECTED VALUE. ACCORDING TO THE LOGBOOK THE CONCERNED DEVICE WAS ALREADY IN VENTILATION MODE FOR 4 DAYS. IT FAILED DURING PATIENT VENTILATION DIRECTLY AFTER IT HAD POSTED ¿BLOWER DEFECT" (00.A008) ALARM. THE DEVICE INTERNAL MONITORING OF THE BLOWER ROTATION SPEED HAD OBSERVED A DEVIATION AND TRIGGERED THE STOP OF VENTILATION WITH ALARM AS SPECIFIED FOR THIS CONDITIONS. THE BREATHING SYSTEM WAS OPENED TO ATMOSPHERE TO ALLOW SPONTANEOUS BREATHING OF THE PATIENT. POSSIBLE ORIGINATORS OF ERROR CODE ¿00.A008¿ ARE THE PCB ELCO, PCB MOTOR-CONTROLLER AND THE MOTOR-BLOWER. THESE COMPONENTS WERE REPLACED DURING ON SITE REPAIR. THEY WERE SENT TO THE MANUFACTURER FOR INVESTIGATION AND OPERATED IN A CARINA BREAD BOARDING FOR MORE THAN 620 HOURS WITHOUT PROBLEMS. FURTHERMORE THIS TEST-CARINA WAS SWITCHED OFF AND RE-STARTED MORE THAN 50 TIMES WITHOUT ANY UNACCEPTABLE TURBINE ROTATION SPEED. FINALLY IT CANNOT BE CONFIRMED THAT ONE OF THE TESTED COMPONENTS HAS CAUSED THE REPORTED EVENT. POSSIBLY THE PROBLEM CAN BE ATTRIBUTED TO THE INTERNAL CABLING OF THE DEVICE. THE CABLING WAS RE-FIXATED IN THE COURSE OF REPLACEMENT OF THE MENTIONED COMPONENTS. THE CONCERNED CARINA IS MORE THAN FIVE YEARS OLD AND WAS IN USE FOR 20.000 HOURS. FINALLY THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED.

    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 THE DEVICE POSTED A DEVICE FAILURE ALARM (00.A008) WHILE IN USE. IN CASE OF THIS FAILURE THE DEVICE GENERATES OPTICAL AND ACOUSTICAL ALARM AND STOPS VENTILATION. THE CUSTOMER IMMEDIATELY REPLACED THE DEVICE. NO INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267728 CARINA VENTILATORS, OTHER CBK DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1