BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 5220841 · Received November 12, 2015

    Report

    Report Number
    2021710-2015-02188
    Event Type
    Malfunction
    Date Received
    November 12, 2015
    Date of Event
    October 13, 2015
    Report Date
    October 13, 2015
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS (FA) REPRESENTATIVE (REP) RECEIVED THE SUSPECT COMPONENT. THE CAREFUSION FA REP REPORTED MOISTURE INGRESS ON SCREEN, THE GROUND ON THE TOUCH SCREEN CABLE WAS BURNT. THE CAREFUSION FA REP INSTALLED THE SUSPECT COMPONENT IN A KNOWN GOOD UNIT WITH KNOWN GOOD PCBA (PRINTED CIRCUIT BOARD ASSEMBLY) MAIN BOARD. THE CAREFUSION FA REP REPORTED TOUCH SCREEN WAS NOT RESPONSIVE. THE CAREFUSION FA REP DETERMINED THE ROOT-CAUSE TO THE FRONT PANEL MOISTURE INGRESS WHICH IS A KNOWN ISSUE THAT IS BEING CORRECTED INTERNALLY WITHIN CAREFUSION.

    Additional Manufacturer Narrative · 1

    CAREFUSION FILE IDENTIFICATION: (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. (B)(4). THE SUSPECT DEVICE HAS NOT BEEN RECEIVED BY CAREFUSION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TOUCH SCREEN WAS NOT RESPONDING WHEN TOUCHED WHILE USING THE VELA VENTILATOR. THE CUSTOMER REPORTED THERE WAS SOME SPOT ON THE SCREEN. THE CUSTOMER REPORTED CROSS CHECKING THE FRONT PANEL TO CONFIRM THE DEFECT AND PERFORMED ALL CALIBRATIONS. THE FAULT FOUND WAS DURING TESTING AND NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751377 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION VELA COMP D

    Patients

    Seq Age Sex Outcome Treatment
    1