BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 4232649 · Received September 12, 2014

    Report

    Report Number
    2021710-2014-00051
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 3, 2014
    Report Date
    August 3, 2014
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOREIGN DISTRIBUTOR DID NOT SUBMIT A USER FACILITY/IMPORTER REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFORMATION PROVIDED BY THE FOREIGN DISTRIBUTOR. (B)(4). BASED ON THE INFORMATION PROVIDED BY THE FOREIGN DISTRIBUTOR, THE CAREFUSION TECHNICAL SUPPORT SPECIALIST DETERMINED THAT THE MOST LIKELY ROOT CAUSE IN THIS REPORTED EVENT IS A FAULTY GAS DELIVERY ENGINE. A REPLACEMENT GAS DELIVERY ENGINE WAS SENT TO THE FOREIGN DISTRIBUTOR ON (B)(4) 2014 FOR THEM TO REPAIR THE DEVICE. CAREFUSION ISSUED A RETURN OF THE ALLEGED FAULTY GAS DELIVERY ENGINE FOR EVALUATION. AS OF 09/11/2014, THE ALLEGED FAULTY GAS DELIVERY ENGINE HAS NOT BEEN RECEIVED. SHOULD THE GAS DELIVERY ENGINE RETURN FOR EVALUATION, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS REPORTED TO CAREFUSION (B)(4) TECH SUPPORT BY A FOREIGN DISTRIBUTOR AND RELAYED TO CAREFUSION VIA EMAIL. USER DESCRIBED THE VENTILATOR WAS ON PATIENT WHEN THE EVENT HAPPENED, MONITOR ALARMED FIRST, AND FOUND THE UNIT HAD NO GAS DELIVERY, BUT IT DID NOT ALARM. THEN THEY IMMEDIATELY REPLACED THE VENTILATOR, SO THE PATIENT WAS NOT HURT. AFTER SHUTDOWN AND REBOOT THE VENTILATOR, THEY FOUND THERE WAS NO AUDIBLE ALARM HEARD. THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM A WARRANTY CLAIM FORM SUBMITTED BY THE FOREIGN DISTRIBUTOR. "NO AUDIBLE ALARMS. UNIT CAN POWER ON, AND OPERATE AS NORMAL. BUT HAS NO AUDIBLE ALARM. CHANGE WITH A GOOD GDE (GAS DELIVERY ENGINE), THE AUDIBLE ALARMS CAN BE HEARD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563674 CAREFUSION CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ASKU