BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 19226028 · Received May 1, 2024

    Report

    Report Number
    2518422-2024-24260
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 24, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE DEVICE WOULD ONLY RUN ON BATTERY POWER. 1. VERIFY ALTERNATING CURRENT (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 POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD ASSEMBLY (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. IN A GOOD FAITH EFFORT (GFE) RESPONSE FROM THE CUSTOMER RECEIVED ON 09MAY2024, IT WAS STATED THAT THE CUSTOMER HAD FOUND THROUGH THE TROUBLESHOOTING STEPS PROVIDED THAT THE PM PCBA NEEDED TO BE REPLACED. ONCE THE PM PCBA WAS REPLACED, THE CUSTOMER STATED THAT THE DEVICE BEGAN TO RUN ON AC POWER WITH NO ISSUES. 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 WOULD ONLY RUN ON BATTERY POWER. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865570 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown