BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 21447735 · Received February 24, 2025

    Report

    Report Number
    2518422-2025-021328
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    February 6, 2025
    Report Date
    March 6, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FSE EVALUATED THE DEVICE AS THE CUSTOMER SITE AND REPLACED THE POWER SUPPLY. FOLLOWING THE REPLACEMENT OF THE POWER SUPPLY, THE DEVICE WAS ABLE TO CHARGE THE BACKUP BATTERY, AND ALL TESTING INCLUDED IN THE PERFORMANCE VERIFICATION TEST (PVT) WAS PASSED. THE DEVICE MET SPECIFICATION WAS RETURNED TO USE. 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 ON THE V60 VENTILATOR INDICATING THAT THE DEVICE WAS NOT OPERATING ON ALTERNATING CURRENT (AC) POWER. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE REMOTE SERVICE ENGINEER (RSE) ADVISED THE CUSTOMER THAT THE LATEST REVISION OF THE SERVICE MANUAL WAS VERSION T. THE RSE PROVIDED THE CUSTOMER WITH THE FOLLOWING TROUBLESHOOTING STEPS: 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 PM 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; 4. VERIFY THAT AC POWER IS PRESENT; A. DISCONNECT AC POWER; B. REMOVE 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 RSE THEN GAVE THE CUSTOMER THE PART INFORMATION FOR THE V60 POWER SUPPLY, AND THE CUSTOMER REQUESTED ONSITE SERVICE BY A FIELD SERVICE ENGINEER (FSE). THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612166 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown