BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 18344229 · Received December 18, 2023

    Report

    Report Number
    2518422-2023-36180
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    December 12, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ON 19DEC2023, THE CUSTOMER INFORMED A PHILIPS REMOTE SERVICE ENGINEER (RSE) THAT THE POWER SUPPLY WAS REPLACED, AND THE DEVICE BEGAN TO OPERATE ON AC POWER AND CHARGED THE BATTERY. THE V60 PASSED PERFORMANCE VERIFICATION TESTING (PVT) AND ALARM, POWER FAIL, AND INTERNAL BATTERY TESTING. 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 NOT POWER ON USING DIRECT CURRENT (DC) OR 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 CUSTOMER WAS PROVIDED WITH THE FOLLOWING TROUBLESHOOTING STEPS FROM THE PHILIPS REMOTE SERVICE ENGINEER (RSE): 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 CUSTOMER FOUND THAT 118.8 VOLTS WERE COMING GOING INTO THE DEVICE. THE RSE ADVISED THE CUSTOMER TO REPLACE THE POWER SUPPLY AND PROVIDED THE REPLACEMENT PART INFORMATION. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982852 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown