BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 23960718 · Received January 5, 2026

    Report

    Report Number
    2518422-2026-100011
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 10, 2025
    Report Date
    January 5, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60 INDICATING THAT AN OVERVOLTAGE PROTECTION (OVP) CIRCUIT FAILURE OCCURRED. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. IT WAS REPORTED THAT AN OVP CIRCUIT FAILURE OCCURRED. THE REMOTE SERVICE ENGINEER (RSE) CONFIRMED THE ERROR CODE IN THE EVENT LOG. A PHILIPS AUTHORIZED SERVICE PROVIDER (ASP) THEN WENT ONSITE AND WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. THE CUSTOMER THEN STATED THE OVP CIRCUIT FAILURE OCCURRED INTERMITTENTLY. THE PHILIPS ASP THEN REPLACED THE POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AND MOTOR CONTROLLER (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) TO RESOLVE THE REPORTED ISSUE. THE CUSTOMER REPLACED THE PM PCBA AND MC PCBA 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19696 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown