BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELA VENTILATOR

    MDR report key: 10463265 · Received August 27, 2020

    Report

    Report Number
    2021710-2020-12468
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    August 3, 2020
    Report Date
    August 3, 2020
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446001419
    PMA / PMN Number
    K093094
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: VYAIRE FAILURE ANALYSIS WAS ABLE TO CONFIRMED AND DUPLICATE THE REPORTED ISSUE. INVESTIGATION REVEALED THE TURBINE INTERFACE PCB (POWER CIRCUIT BOARD ANALOG) P/N: 29415-001 S/N: (B)(6) REV A HAS BECOME CORRUPTED AND IS FAILING. THIS IS CONSIDERED A KNOWN ISSUE ADDRESSED WITH CAPA CA-2015-0401 AND ECO 100818 EEPROM (ELECTRICALLY ERASABLE PROGRAMMABLE READ ONLY MEMORY) FAILED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VELA VENTILATOR ALARMED LOW EXHALED VOLUME (VE) AND THE TURBINE GENERATES BURNING SMELL AND SEEMED GOT STUCK. THE ISSUE OCCURRED DURING PATIENT-USE AND THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926276 VELA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL VELA 10846446001419

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention