BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 6206702 · Received December 27, 2016

    Report

    Report Number
    2021710-2016-05109
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    November 28, 2016
    Report Date
    May 7, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: CAREFUSION FAILURE ANALYSIS LAB TECHNICIAN WAS ABLE TO VERIFY THE CUSTOMER'S REPORTED ISSUE. ALL TRANSDUCERS WERE CALIBRATING CORRECTLY. THE FAILURE APPEARS TO BE INTERMITTENT AND NOT CONSISTENTLY REPEATABLE.

    Additional Manufacturer Narrative · 1

    CAREFUSION COMPLAINT NUMBER: (B)(4). IN THE EVENT THE DEVICE IS RECEIVED FOR EVALUATION OR ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT'S ERROR LOG SHOWED THAT A TRANSDUCER FAULT OCCURRED. THE UNIT WAS ALSO FAILING THE EXHALATION FLOW TRANSDUCER CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856043 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1