BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 23729419 · Received December 5, 2025

    Report

    Report Number
    2518422-2025-058855
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    January 17, 2025
    Report Date
    December 19, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP WAS PERFORMED WITH THE KEY MARKET (KM), AND THE RESPONDER REPORTED THAT CUSTOMER REPLACED THE MOTOR CONTROL (MC) BOARD TO RESOLVE THE ISSUE. THE DEVICE WASE 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 FROM THE CUSTOMER, REPORTING THAT THE V60 VENTILATOR DISPLAYED A 3.3 VOLT (V), AND 5 V ALARMS. THE DEVICE WAS NOT IN CLINICAL USE WHEN THE ISSUES OCCURRED. NO PATIENT OR USER HARM REPORTED. THE CUSTOMER REPORTED THAT DURING THE START UP OF THE DEVICE, ERROR CODES "3.3 V SUPPLY FAILED", AND "5V SUPPLY FAILED" WERE OBSERVED. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2107540 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown