BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 22211467 · Received June 16, 2025

    Report

    Report Number
    2518422-2025-047413
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    May 28, 2025
    Report Date
    August 5, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: UPON FURTHER INVESTIGATION, THIS RECORD WAS DETERMINED TO BE A DUPLICATE RECORD OF MFR REPORT NUMBER 2518422-2025-031960. THE INVESTIGATION WILL BE DOCUMENTED UNDER MFR REPORT NUMBER 2518422-2025-031960. THEREFORE, THIS COMPLAINT NO LONGER MEETS REPORTABILITY REQUIREMENTS.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT THE SCREEN WAS VERY DIM. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM WAS REPORTED. THE CUSTOMER CALLED TECHNICAL SUPPORT TO REPORT THAT THE SCREEN WAS VERY DIM. THE CUSTOMER REQUESTED THE REPLACEMENT USER INTERFACE (UI) ASSEMBLY TO BE ORDERED UNDER CONTRACT. THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008441 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown