BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 5108806 · Received September 28, 2015

    Report

    Report Number
    2021710-2015-01798
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 1, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION DISPATCHED A CAREFUSION FIELD SERVICE REPRESENTATIVE TO THE USER FACILITY TO EVALUATE AND REPAIR THE DEVICE. THE CAREFUSION FIELD SERVICE REPRESENTATIVE HAS NOT COMPLETED THE EVALUATION OF THE DEVICE AS OF (B)(6) 2015. ONCE THE EVALUATION AND REPAIR OF THE DEVICE HAS BEEN COMPLETED CAREFUSION WILL SUBMIT A FOLLOW-UP MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    CAREFUSION FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DUPLICATE THE CUSTOMER'S REPORTED ISSUE. THE UNIT PASSED ALL TESTING AND MET ALL CAREFUSION MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 1

    THE USER FACILITY REPRESENTATIVE REPORTED THAT THE DEVICE HAS A CONSTANT AUDIBLE ALARM WITH NO VISUAL ALARM INDICATION AND THAT THE DEVICE'S TOUCH SCREEN IS UNRESPONSIVE TO TOUCH. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638545 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION VELA

    Patients

    Seq Age Sex Outcome Treatment
    1