BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 21349673 · Received February 10, 2025

    Report

    Report Number
    2518422-2025-014150
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 24, 2025
    Report Date
    April 18, 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

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS BENCH SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE OXYGEN SENSOR WAS NOT BEING DETECTED. THE BENCH SERVICE ENGINEER (BSE) EVALUATED THE DEVICE THE DEVICE ON (B)(6) 2025 AT A BENCH SERVICE CENTER. THE OXYGEN SENSOR WAS NOT DETECTED BY THE DEVICE, SO THE BSE CONNECTED A DIFFERENT FLOW SENSOR ASSEMBLY (FSA) TO THE DEVICE, AND IT WAS DETECTED AS EXPECTED. A REPLACEMENT FSA WAS CONFIRMED TO BE REQUIRED. THE BSE WAS UNABLE TO RETRIEVE THE DEVICES DIAGNOSTIC REPORT (DRPT). ON (B)(6) 2025, THE BSE REPLACED THE FSA 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. THE DEVICE WAS REPORTED TO BE OUTSIDE OF USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE OXYGEN SENSOR WAS NOT BEING DETECTED. 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 ON 24JAN2025 AT A BENCH SERVICE CENTER. THE OXYGEN SENSOR WAS NOT DETECTED BY THE DEVICE, SO THE BSE CONNECTED A DIFFERENT FLOW SENSOR ASSEMBLY (FSA) TO THE DEVICE AND IT WAS DETECTED AS EXPECTED. A REPLACEMENT FSA WAS CONFIRMED TO 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
    684435 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838090996

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown