BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 3042384 · Received March 20, 2013

    Report

    Report Number
    2021710-2013-00017
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Removal / Correction Number
    Z-0510-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT PROVIDE ANY PT OR DEVICE CODES ON THEIR USER FACILITY REPORT. CODES WERE DERIVED BASED ON THE INFO PROVIDED BY THE USER FACILITY MEDWATCH REPORT RECEIVED FROM THE FDA ON (B)(6) 2013. THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CAREFUSION FIELD SERVICE REP AND THE CAREFUSION FAILURE ANALYSIS LAB TECHNICIAN. THE CAREFUSION FIELD SERVICE REP EVALUATED THE DEVICE AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS A FAULTY GAS DELIVERY ENGINE (GDE). THE CAREFUSION FIELD SERVICE REP COMPLETED THE REPAIR OF THE DEVICE BY REPLACING THE GAS DELIVERY ENGINE (GDE), UPDATED SOFTWARE AND RUNNING THE DEVICE THROUGH A COMPLETE CHECKOUT PER THE OPERATOR'S AND SERVICE MANUALS. UPON COMPLETION THE DEVICE WAS RETURNED TO THE CUSTOMER TO BE PLACED BACK INTO SERVICE. THE CAREFUSION FAILURE ANALYSIS LAB TECHNICIAN EVALUATED THE ALLEGED FAULTY GAS DELIVERY ENGINE (GDE), VERIFIED THE NO VENTILATION CONDITION, HOWEVER, WAS NOT ABLE TO CONFIRM OR REPRODUCE THE ALLEGED NO ALARM CONDITION AS THE GAS DELIVERY ENGINE GENERATED AN AUDIBLE AND VISUAL ALARM. THE CAREFUSION FAILURE ANALYSIS LAB TECHNICIAN DETERMINED THAT THE ROOT CAUSE OF THE REPORTED NO VENTILATION CONDITION WAS A FAULTY EXPIRATORY PRESSURE XDCR ON THE TCA PCBA. FAILURE OF THE EXPIRATORY PRESSURE XDCR IS A KNOWN ISSUE RELATED TO THE TCA PCBA IN THE GAS DELIVERY ENGINE. CAREFUSION HAS INITIATED A VOLUNTARY FIELD CORRECTION TO ADDRESS THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT AND THE CONDITION OF THE PATIENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY CAREFUSION FROM THE FDA ON (B)(6) 2013. "DEVICE USAGE PROBLEM: DEVICE FAILED (BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)". "DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114811 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR ASKU