BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 9521798 · Received December 26, 2019

    Report

    Report Number
    2021710-2019-11206
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    December 5, 2019
    Report Date
    December 5, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VYAIRE SERVICE TECHNICIAN WAS ABLE TO CONFIRM THE REPORTED COMPLAINT THROUGH THE EVENTS LOG AND DUPLICATED DURING FUNCTIONAL CHECK. THE CAUSE WAS DETERMINED TO BE A SOLENOID FAILURE. CAPA CO# 101543 ADDRESSED THE ISSUE.

    Additional Manufacturer Narrative · 1

    VYAIRE COMPLAINT NUMBER (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 LOW PEAK INSPIRATORY PRESSURE, LOW MINUTE VENTILATION, AND HIGH RATE SIMULTANEOUSLY. 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
    1315203 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001358

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown