BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 4848152 · Received June 12, 2015

    Report

    Report Number
    2021710-2015-01109
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    December 14, 2014
    Report Date
    May 12, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE THE CAREFUSION FIELD SVC REP WAS NOT AWARE OF THE REPORTED FAILURE, HE PERFORMED A REGULAR SCHEDULED PREVENTATIVE MAINTENANCE WITHOUT ENCOUNTERING ANY ISSUES AND PER THE SVC MANUAL HE RAN THE DEVICE THROUGH A COMPLETE OPERATIONAL VERIFICATION PROCEDURE TO ENSURE THAT THE DEVICE MEETS FACTORY SPEC. UPON COMPLETION THE DEVICE WAS RELEASED BACK TO THE USER FACILITY READY TO BE PLACED BACK INTO SVC. CARE FUSION SENT AN EMAIL TO THE USER FACILITY SEEKING ADD'L INFO CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE PT. AS OF JUNE 10, 2015 THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM A MAUDE EVENT REPORT REC'D BY CAREFUSION FROM THE FDA ON MAY 12, 2015. "VENTILATOR ALARMING -CODE WAS ALARMING LOW O2. AIR COULD BE HEARD LEAKING OUT OF THE BACK OF VENTILATOR. NO INJURY TO PT. VENTILATOR REMOVED FROM SVC, NEW VENTILATOR PUT INTO USE ON PT." THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE(S). "GOT PHONE CALL BACK FROM [NAME REMOVED]. SHE CONFIRMED VENT S/N (B)(4) TO BE THE VENT INVOLVED. I ASKED IF IT HAS BEEN REPAIRED SHE SAID YES, CAREFUSION FSE [FIELD SVC] FIXED IT ON CALL (B)(4). I INDICATED TO HER THAT CALL (B)(4) WAS FOR SIMPLE PM. SHE SAID THAT THEY DID NOT CALL IT IN SEPARATELY FOR THE REPAIR BECAUSE THEY KNEW [NAME REMOVED] WAS ALREADY COMING OUT AND THEY WOULD HAVE HIM DO IT DURING THE PM. EXPLAINED TO HER THAT ALL VENTS THAT HAVE PROBLEM NEED TO BE CALLED IN SEPARATELY SO THAT CAREFUSION KNOWS VENTS ARE DOWN AND WE CAN ISSUE FLD SRVC CALLS [FIELD SVC CALL], TREND REPAIRS AND FAILURES. SHE SAID SHE NOW UNDERSTANDS AND WILL EDUCATE HER STAFF TO MAKE SURE ALL VENT PROBLEMS ARE REPORTED TO TECH SUPPORT AS SOON AS THEY HAPPEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383685 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION VELA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention