BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 18866197 · Received March 8, 2024

    Report

    Report Number
    2518422-2024-12834
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    February 21, 2024
    Report Date
    March 30, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER PHONE CALL WITH THE BME, THE BME CONFIRMED THAT THE REPLACEMENT POWER SUPPLY WAS ULTIMATELY ORDERED FOR REPAIR. UPON RECEIVING THE NEW POWER SUPPLY, THE BME PERFORMED THE POWER SUPPLY REPLACEMENT AND VERIFIED THAT THE ISSUE WAS RESOLVED. THE DEVICE PASSED THE REQUIRED PERFORMANCE VERIFICATION TESTS PER PHILIPS STANDARD AND WAS RETURNED TO SERVICE. 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 BY THE BIOMEDICAL ENGINEER (BME) ON THE V60 INDICATING THAT THERE WAS A LOSS OF ALTERNATING CURRENT (AC) POWER, AND THE DEVICE WAS ONLY RUNNING ON BATTERY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE BIOMEDICAL ENGINEER (BME) CALLED TECHNICAL SUPPORT TO REPORT THAT THERE WAS A LOSS OF ALTERNATING CURRENT (AC) POWER, AND THE DEVICE WAS ONLY RUNNING ON BATTERY. THE REMOTE SERVICE ENGINEER (RSE) PERFORMED TROUBLESHOOTING WITH THE BME PER THE 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 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. THE BME SAW 120 COMING IN AND REQUESTED FOR THE PART NUMBER AND PRICE OF THE REPLACEMENT POWER SUPPLY FOR REPAIR. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171149 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown