BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 17435987 · Received August 1, 2023

    Report

    Report Number
    2518422-2023-17811
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 20, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS TO RETRIEVE DEVICE REPAIR, AND OPERATIONAL STATUS HAS YIELDED NO RESPONSE FROM THE CUSTOMER. THE COMPLAINT WILL BE PROCESSED FOR CLOSURE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, THE COMPLAINT WILL BE REOPENED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE SYSTEM WOULD NOT POWER UP ON ALTERNATING CURRENT (AC) POWER. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT HARM REPORTED. THE CUSTOMER INFORMED THE REMOTE SERVICE ENGINEER (RSE) THAT THE DEVICE WAS OPERATING CORRECTLY ON BATTERY POWER. THE CUSTOMER WAS PROVIDED 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; 6. 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 PROVIDED THE CUSTOMER WITH THE PART INFORMATION FOR THE POWER CORD, 2ND GEN POWER SUPPLY, 1ST GEN POWER SUPPLY, AND THE AC INLET. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338741 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown