BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 23477057 · Received November 5, 2025

    Report

    Report Number
    2518422-2025-051519
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 17, 2025
    Report Date
    January 14, 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

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS HAVE BEEN MADE ON 24NOV2025, 12DEC2025, AND 31DEC2025 TO TRY TO OBTAIN FURTHER INFORMATION ABOUT THIS CASE, BUT NO RESPONSE RECEIVED FROM THE CUSTOMER. 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 DEVICE RECEIVED ERROR CODE OVERVOLTAGE PROTECTION CIRCUIT FAILURE (OVP) CIRCUIT FAILED MESSAGE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE CUSTOMER EVALUATED THE DEVICE WITH THE ASSISTANCE OF THE REMOTE SERVICE ENGINEER (RSE) AND CONFIRMED THE REPORTED PROBLEM. THE CUSTOMER STATED THAT THE DEVICE WAS GIVING ERROR CODE OVP CIRCUIT FAILED, AND IT WAS CONFIRMED IN EVENT LOG. THE 12/3.3 V OVP CIRCUIT DID NOT DETECT A 3.3 V OVER-VOLTAGE CONDITION EITHER (1) WITHIN 100 MSEC AFTER THE 3.3 V AND/OR THE 12 V OVP TEST SIGNAL WAS ENABLED OR (2) THE 3.3 V AND/OR 12 V OVP TEST SIGNAL WAS ENABLED LONGER THAN 200 MSEC. THE RSE INFORMED CUSTOMER THAT MANUFACTURER RECOMMENDS REPLACEMENT OF THE MOTOR CONTROLLER (MC) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) OR REPLACE THE POWER MANAGEMENT (PM) PCBA. THE RSE PROVIDED BOTH PARTS TO THE CUSTOMER FOR THE REPAIR. DEVICE EVALUATION AND REPAIR ARE PENDING, AND THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2649415 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown