BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARINA

    MDR report key: 4902750 · Received July 1, 2015

    Report

    Report Number
    9611500-2015-00121
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    April 28, 2015
    Report Date
    September 11, 2015
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    PMA / PMN Number
    K072885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE LOG FILE ANALYSIS REVEALED THAT THE UNIT WAS IN USE ON JULY 2ND, 2014, POWERED BY MAINS SUPPLY. A DROP OF THE SUPPLY VOLTAGE HAD BEEN DETECTED TO WHICH THE DEVICE RESPONDED AS SPECIFIED BY SWITCHING TO BATTERY OPERATION. SHORTLY AFTERWARDS THE ALARM "INT. BATTERY EMPTY !!!" WAS POSTED AND, WITH AN EMPTY BATTERY THE DEVICE SWITCHES TO STANDBY MODE. THE SAME SEQUENCE OF TRIGGERING CONDITIONS HAPPENED ON (B)(4) 2015 WITH NO ACTIVITIES AT ALL AT THE DEVICE BETWEEN THESE DATES. THE RETURNED PCB DC POWER SUPPLY WAS OPERATED IN A CARINA BREAD BOARDING FOR MORE THAN 260 HOURS WITHOUT ANY PROBLEMS. THE RETURNED AC/DC POWER SUPPLY AND THE BATTERY WERE OPERATED FOR MORE THAN 300 HOURS WITHOUT OBSERVATION OF NONCONFORMITIES. NO TECHNICAL ISSUE WAS FOUND DURING THE INVESTIGATION - HOWEVER, THE REPORTED CONDITION COULD BE CONFIRMED AND ALL THE ASSEMBLIES THAT MIGHT BE PUT IN CAUSAL CONNECTION WERE ALREADY REPLACED ON-SITE. IT TURNED OUT THAT THE DEVICE WAS STORED FOR APPROX. 8 MONTHS WITHOUT RECHARGING THE INTERNAL BATTERY WHICH IS THE MOST LIKELY EXPLANATION FOR THE USER'S REPORT. NO PATIENT CONSEQUENCES HAVE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE PERFORMED A SHUTDOWN WHILE IN USE. NO INJURY REPORTED.

    Description of Event or Problem · 1

    PLEASE SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429668 CARINA VENTILATORS, OTHER CBK DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1