BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 7215938 · Received January 24, 2018

    Report

    Report Number
    2021710-2018-07342
    Event Type
    Injury
    Date Received
    January 24, 2018
    Date of Event
    August 27, 2017
    Report Date
    April 23, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE REFERENCE NUMBER: (B)(4). AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FROM THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED OR A FINAL EVALUATION IS PERFORMED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    RESULT 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 A FAILED PRESSURE TRANSDUCER (PT802), WHICH WAS UNABLE TO BE CALIBRATED AND ALSO FAILED EXHALATION FLOW TRANSDUCER (PT 801).

    Additional Manufacturer Narrative · 1

    THE SUSPECT COMPONENT, A MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA), WAS RETURNED AND RECEIVED BY VYAIRE MEDICAL, INC. AND IS PENDING FAILURE ANALYSIS EVALUATION. UPON COMPLETION OF THE FINAL EVALUATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR VELA VENTILATOR ALARMED "TRANSDUCER FAULT" WHILE IN USE WITH A PATIENT. THE CUSTOMER REPLACED THE MAIN PRINTED CIRCUIT BOARD AND THE ISSUE WAS RESOLVED. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60808 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC VELA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention