BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 6077909 · Received November 3, 2016

    Report

    Report Number
    2021710-2016-04789
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 5, 2016
    Report Date
    January 6, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: IT WAS REPORTED THAT A CAREFUSION FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE DEVICE ONSITE. THE FSR DUPLICATED THE REPORTED ISSUE AND REPLACED THE BLANK SCREEN AND RETURNED IT WORKING TO SERVICE SPECIFICATIONS. AT THIS TIME THE PART IS NOT AVAILABLE FOR EVALUATION. IF THE DEVICE IS RETURNED THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE SCREEN ON THIS UNIT FLICKERS AND THEN GOES BACK. WHEN CYCLING POWER IT DOES THE SAME THING. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728551 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1