BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 9386866 · Received November 27, 2019

    Report

    Report Number
    2021710-2019-11065
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    November 3, 2019
    Report Date
    November 3, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446001358
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE COMPLAINT NUMBER (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION. THE VYAIRE TECHNICIAN EVALUATED THE DEVICE AND PERFORMED TESTS. THE REPORTED COMPLAINT WAS ABLE TO BE CONFIRMED THROUGH THE EVENTS LOG, BUT COULD NOT DUPLICATED DURING FUNCTIONAL CHECK. CAUSE WAS IDENTIFIED AS SLOW SOLENOIDS. ROOT CAUSE IS BEING INVESTIGATED UNDER CO# 101543

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER WILL BE INCLUDED IN A FOLLOW UP REPORT. AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE THAT THE VELA VENTILATOR ALARMED TRANSDUCER FAULT, LOW PIP, MOTOR FAULT, AND VENTILATOR INOPERABLE UPON START-UP. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181298 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001358

    Patients

    Seq Age Sex Outcome Treatment
    1