BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA

    MDR report key: 8741815 · Received June 27, 2019

    Report

    Report Number
    2021710-2019-10438
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    May 30, 2019
    Report Date
    May 31, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    70846446001442
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: D10, H3, H6, AND H10. RESULTS OF INVESTIGATION: THE VYAIRE FAILURE ANALYSIS LAB RECEIVED THE SUSPECTED DEVICE/COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED "TOUCH SCREEN DELAMINATION- DOES NOT RESPOND" PROBLEM WAS CONFIRMED. THIS IS A KNOWN ISSUE ADDRESSED THROUGH ECO 82509.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE TRAINED CUSTOMER REPORTED THE SUSPECT DEVICE/COMPONENT WILL BE RE-WORKED WITH A REPLACEMENT FRONT PANEL DISPLAY FPD) ASSEMBLY. HOWEVER, NO FPD COMPONENT IS AVAILABLE FOR ANALYSIS. IN THE EVENT THAT THE FPD IS RECEIVED FOR EVALUATION OR ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNRESPONSIVE TOUCH SCREEN DISPLAY AND A DELAMINATED DISPLAY, ON THIS VENTILATOR DEVICE. THE CUSTOMER STATED NO PATIENT INVOLVEMENT WITH THIS EVENT. ADDITIONALLY, THE CUSTOMER DETERMINED THE LIKELY FAULTY ASSEMBLY WAS A COMPONENT WITHIN THE FRONT PANEL DISPLAY AND A REPLACEMENT WAS ORDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532686 VELA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 70846446001442

    Patients

    Seq Age Sex Outcome Treatment
    1