BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 24402392 · Received February 20, 2026

    Report

    Report Number
    2518422-2026-103245
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    February 4, 2026
    Report Date
    March 9, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER LATER PROVIDED THE INFORMATION THAT THE REPLACEMENT POWER SUPPLY WAS ULTIMATELY ORDERED AND INSTALLED, AFTER WHICH THE ISSUE WAS RESOLVED. THE DEVICE PASSED THE REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARD AND WAS RETURNED TO SERVICE. THE DEVICE PASSED THE REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARD AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER ON THE V60 VENTILATOR INDICATING THAT THE DEVICE ONLY RAN ON DIRECT CURRENT (DC) POWER WHEN PLUGGED IN. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. NO PATIENT OR USER HARM WAS REPORTED. THE REMOTE SERVICE ENGINEER (RSE) PERFORMED TROUBLESHOOTING WITH THE CUSTOMER, AND THE CUSTOMER ATTEMPTED A DIFFERENT POWER CORD; HOWEVER, THE ISSUE REMAINED. THE RSE INSTRUCTED THE CUSTOMER TO PERFORM THE FOLLOWING STEPS ACCORDING TO THE V60 SERVICE MANUAL: 1. VERIFY AC OUTLET FOR PROPER VOLTAGE. 2. VERIFY THAT POWER CORD IS FUNCTIONAL. 3. VERIFY POWER SUPPLY (24V): A. WITH AC POWER DISCONNECTED, REMOVE J1 FROM POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). B. RECONNECT AC POWER. C. VERIFY THAT 24V IS PRESENT BETWEEN THE ORANGE AND BROWN WIRES ON THE POWER SUPPLY HARNESS CONNECTOR. D. IF 24V IS PRESENT, REPLACE THE PM PCBA. E. IF 24V IS NOT PRESENT, GO TO NEXT STEP. THE CUSTOMER INDICATED THAT 24V IS NOT PRESENT, AND THUS REFERRED TO THE NEXT STEPS: 4. VERIFY THAT AC POWER IS PRESENT: A. DISCONNECT AC POWER. B. REMOVE ELECTROMAGNETIC INTERFERENCE (EMI) SHROUD. C. RECONNECT AC POWER. D. VERIFY THAT AC VOLTAGE IS PRESENT BETWEEN THE BLUE AND BROWN WIRES COMING FROM THE AC INLET. E. IF AC POWER IS PRESENT, REPLACE THE POWER SUPPLY. F. IF AC POWER IS NOT PRESENT, REPLACE THE AC INLET. THE CUSTOMER CONFIRMED THAT 120V WAS PRESENT. THE RSE INFORMED THE CUSTOMER THAT THE MANUFACTURER RECOMMENDS REPLACING THE POWER SUPPLY TO REMEDY THE ISSUE AND PROVIDED THE CUSTOMER WITH PART NUMBER OF THE REPLACEMENT POWER SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547124 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown