BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 19028100 · Received April 2, 2024

    Report

    Report Number
    2518422-2024-16888
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 15, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS AN OVER VOLTAGE PROTECTION (OVP) CIRCUIT FAILURE. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. UPON REVIEWING THE ERROR LOG OF THE V60 DEVICE, IT WAS FOUND THAT THERE WAS AN OVP CIRCUIT FAILURE WHICH WAS ALSO CAUSING A SPI BUS FAILURE TO OCCUR. ON (B)(6) 2024, THE POWER MANAGEMENT (PM) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) WAS REPLACED TO RESOLVE THE OVP AND SPI BUS ISSUES. THE DEVICE PASSED ALL THE TESTING REQUIRED FOR A PERFORMANCE VERIFICATION TEST 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623043 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown