BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 7131745 · Received December 19, 2017

    Report

    Report Number
    2021710-2017-07168
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 20, 2017
    Report Date
    April 26, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE REPRESENTATIVE (FSR) WENT ON-SITE EVALUATE THE SUSPECT DEVICE. THE FSR REPLACED THE NON RESPONSIVE TOUCHSCREEN AND RAN THE OPERATION VERIFICATION PROCEDURE ON THE DEVICE. THE DEVICE PASSED ALL TESTS AND PERFORMED TO MANUFACTURING SPECIFICATIONS. THE SUSPECT TOUCH SCREEN HAS BEEN RECEIVED BY VYAIRE'S FAILURE ANALYSIS LABORATORY AND IS PENDING FURTHER INVESTIGATION. ONCE THE FINAL REPORT IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATIONS: THE VYAIRE FAILURE ANALYSIS LAB RECEIVED THE SUSPECT COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS CONFIRMED AND DUPLICATED IN THE LABORATORY SETTING. THE ROOT CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE WATER INGRESS. THE ROOT CAUSE IN FINAL INVESTIGATION REPORT WAS MENTIONED AS HARDWARE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR VELA VENTILATOR'S TOUCH SCREEN WAS UNRESPONSIVE. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910473 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1