BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 23408178 · Received October 28, 2025

    Report

    Report Number
    2518422-2025-050101
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 7, 2025
    Report Date
    November 20, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE THIRD PARTY THAT THE CUSTOMER INQUIRED REPLACED THE LCD TO RESOLVE THE REPORTED ISSUE. THE DEVICE PASSED REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARDS AND WAS RETURNED TO SERVICE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE DISPLAY WAS DIM. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS REPORTED THAT THE DISPLAY WAS DIM. IT WAS NOTED THAT THE CUSTOMER HAS A 1ST GENERATION LIGHT CRYSTAL DISPLAY (LCD). THE REMOTE SERVICE ENGINEER (RSE) ADVISED THE CUSTOMER TO REPLACE THE USER INTERFACE (UI) ASSEMBLY WITH THE 2ND GENERATION LCD. THE RSE PROVIDED THE CUSTOMER WITH THE PART NUMBER TO ORDER AND REPLACE. DEVICE EVALUATION AND REPAIR ARE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904702 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown