BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELA VENTILATOR

    MDR report key: 8830486 · Received July 26, 2019

    Report

    Report Number
    2021710-2019-10579
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    June 28, 2019
    Report Date
    July 25, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446001501
    PMA / PMN Number
    K093094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENT FOR INVESTIGATION. THE REPORTED COMPLAINT WAS ABLE TO BE CONFIRMED AND DUPLICATED. THERE IS VISIBLE FLUID INGRESS WHICH RESULTS IN MALFUNCTION WITH THE TOUCH SCREEN BECOMING UNRESPONSIVE. THIS ISSUE WILL BE INTERNALLY INVESTIGATED WITHIN VYAIRE.

    Additional Manufacturer Narrative · 1

    CLARIFICATION THAT DEVICE WAS EVALUATED BY VYAIRE MEDICAL'S FAILURE ANALYSIS LABORATORY. ADDITIONAL CLARIFICATION THAT THE SUSPECT DEVICE WAS REPAIRED BY A VYAIRE FIELD SERVICE REPRESENTATIVE AND RETURNED TO THE CUSTOMER TO MANUFACTURER SPECIFICATIONS. THE MOST CONTRIBUTORY COMPONENT WAS IDENTIFIED AND SENT TO VYAIRE'S FAILURE ANALYSIS LABORATORY FOR FURTHER EVALUATION. THE RESULTS OF THE INVESTIGATION (ROI) WAS PROVIDED ON SUPPLEMENTAL MDR REPORT (1).

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE THAT THE VELA VENTILATOR TOUCH SCREEN IS FROZEN, THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625490 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001501

    Patients

    Seq Age Sex Outcome Treatment
    1