BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 17967025 · Received October 19, 2023

    Report

    Report Number
    2518422-2023-27334
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    October 12, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MULTIPLE ATTEMPTS HAVE BEEN MADE ON 07-OCT-2023, 24-OCT-2023, AND 01-NOV-2023 TO TRY TO OBTAIN FURTHER INFORMATION ABOUT THIS CASE, BUT NO RESPONSE WAS RECEIVED FROM THE BIOMEDICAL ENGINEER (BME). THIS FILE IS CLOSED AND CAN BE REOPENED IF NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON THE V60, INDICATING THAT THE BOTTOM OF THE TOUCHSCREEN WAS NOT RESPONSIVE, AND THE TOUCHSCREEN COULD NOT BE CALIBRATED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED. THE CUSTOMER REPORTED TO THE REMOTE SERVICE ENGINEER (RSE) THAT THE BOTTOM OF THE TOUCHSCREEN WAS NOT RESPONSIVE, AND THE TOUCHSCREEN COULD NOT BE CALIBRATED. THE RSE PROVIDED THE PART NUMBER OF THE TOUCHSCREEN TO THE CUSTOMER FOR REPAIR UPON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078954 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown