BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 23899145 · Received December 26, 2025

    Report

    Report Number
    2518422-2025-059108
    Event Type
    Malfunction
    Date Received
    December 26, 2025
    Date of Event
    December 12, 2025
    Report Date
    January 16, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER GOOD FAITH EFFORT RESPONSE RECEIVED, THE DEVICE WAS PUT IN FOR DISPOSAL AND WILL NOT BE REPAIRED. NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT THE DEVICE'S DISPLAY WAS DIM. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE DEVICE WAS TAKEN OUT OF SERVICE. NO PATIENT OR USER HARM WAS REPORTED. THE CUSTOMER ALSO NOTED THAT THE DEVICE IS OVER 15 YEARS OLD AND HAS THE FIRST-GENERATION LIQUID CRYSTAL DISPLAY (LCD). THE REMOTE SERVICE ENGINEER (RSE) PROVIDED THE CUSTOMER WITH THE PART NUMBERS AND PRICES OF THE REPLACEMENT PARTS NEEDED TO UPGRADE THE FIRST-GENERATION LIQUID CRYSTAL DISPLAY (LCD) TO A SECOND-GENERATION LCD AND THE COMPLETE UI ASSEMBLY FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2139282 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown