BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 21375439 · Received February 13, 2025

    Report

    Report Number
    2518422-2025-015732
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    January 24, 2025
    Report Date
    April 22, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838090996
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BENCH SERVICE ENGINEER (BSE) EVALUATED THE DEVICE THE DEVICE AT A BENCH SERVICE CENTER. WHEN THE BSE SELECTED THE "SERVICE" BUTTON IN THE DIAGNOSTIC MODE, THE DEVICE SHUT DOWN AND RESTARTED EACH TIME. THE BSE DETERMINED THAT THE ISSUE WAS BEING CAUSED BY THE CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). A REPLACEMENT CPU PCBA WOULD BE REQUIRED. THE BSE WAS UNABLE TO RETRIEVE THE DEVICES DIAGNOSTIC REPORT (DRPT). THE BSE REPLACED THE CPU PCBA TO RESOLVE THE ISSUE. FOLLOWING THE PART REPLACEMENT THE BSE COMPLETED A PERFORMANCE VERIFICATION TEST (PVT) WHICH THE DEVICE PASSED, CONFIRMING THAT THE DEVICE HAD BEEN RETURNED TO FULL FUNCTIONALITY. THE DEVICE WILL BE RETURNED TO THE CUSTOMER READY FOR USE. 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 DEVICE SHUTDOWN UNEXPECTEDLY. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE BENCH SERVICE ENGINEER (BSE) EVALUATED THE DEVICE THE DEVICE AT A BENCH SERVICE CENTER. WHEN THE BSE SELECTED THE "SERVICE" BUTTON IN THE DIAGNOSTIC MODE, THE DEVICE SHUT DOWN AND RESTARTED EACH TIME. THE BSE DETERMINED THAT THE ISSUE WAS BEING CAUSED BY THE CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). A REPLACEMENT CPU PCBA WOULD BE REQUIRED. THE BSE WAS UNABLE TO RETRIEVE THE DEVICES DIAGNOSTIC REPORT (DRPT). THIS INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125817 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR 00884838090996

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown