BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 10262186 · Received July 12, 2020

    Report

    Report Number
    2031642-2020-02321
    Event Type
    Malfunction
    Date Received
    July 12, 2020
    Report Date
    June 18, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(4) 2020. DATE OF REPORT: 12JUL2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NAV-RING IS NOT WORKING. THE FIELD SERVICE ENGINEER (FSE) VERIFIED THE REPORTED PROBLEM. THE (FSE) FOUND THE NAV-RING CHECK MARK BUTTON IS NOT WORKING. THE FSE COULD NOT ENTER SERVICE MODE. AFTER OPENING THE USER INTERFACE ASSEMBLY, THE FSE NOTICED THE CABLE FROM THE USER INTERFACE BOARD WAS NOT CONNECTED TO THE BOARD BEHIND THE NAV-RING ASSEMBLY PROPERLY. THE CUSTOMER REPORTED THAT THE UNIT WAS NOT IN USE ON A PATIENT. THE FSE RECONNECTED THE CABLE TO THE BOARD BEHIND THE NAV-RING SECURELY TO ADDRESS THE REPORTED PROBLEM. THE FSE WAS ABLE TO ENTER SERVICE MODE WITH NO PROBLEM. THE FSE VERIFIED THE NAV RING AND THE TOUCHSCREEN ARE OPERATING FINE. THE UNIT PASSED THE REQUIRED TEST OF THE PERFORMANCE VERIFICATION SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725899 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1