BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 4860097 · Received June 19, 2015

    Report

    Report Number
    2021710-2015-01131
    Event Type
    Malfunction
    Date Received
    June 19, 2015
    Date of Event
    December 26, 2015
    Report Date
    May 18, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K013642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MAUDE EVENT REPORT # MW5039943 DID NOT CONTAIN ANY INFORMATION REGARDING THE USER FACILITY, OR THE SERIAL NUMBER OF THE DEVICE INVOLVED WHICH WOULD HAVE AIDED CAREFUSION IN DETERMINING IF THE USER FACILITY THAT HAD REPORTED THIS EVENT TO CAREFUSION. AN EXHAUSTIVE REVIEW OF THE CAREFUSION TECHNICAL SUPPORT CALL AND COMPLAINT DATABASES DID NOT FIND ANY CORRESPONDING REPORT FROM A USER FACILITY DURING THE TIME FRAME THAT THIS EVENT WAS REPORTED TO HAVE OCCURRED. THEREFORE CAREFUSION WAS UNABLE TO CONTACT THE USER FACILITY TO MAKE ARRANGEMENTS TO PERFORM AN EVALUATION OF THE DEVICE TO DETERMINE ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM A MAUDE EVENT REPORT # MW5039943 RECEIVED BY CAREFUSION FROM THE FDA ON 05/18/2015. "VOLUN (B)(6) 2015: VENTILATOR HAD A FROZEN SCREEN AND WOULD NOT GIVE BREATHS. ANESTHESIA BAGGED PATIENT WHILE VENTILATOR REPLACED. FLU ACTION: VENT IS OUT OF SERVICE AND BEING REPAIRED. DISPLAY WENT BAD BUT VENT FUNCTIONING AND VENTILATING PT PER BIOMED DEPT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401267 CAREFUSION CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention