BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11646609 · Received April 10, 2021

    Report

    Report Number
    2031642-2021-03354
    Event Type
    Malfunction
    Date Received
    April 10, 2021
    Date of Event
    March 12, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED FAILURE WAS CONFIRMED. FAILURE INVESTIGATION WAS NOT PERFORMED ON THE RETURNED PART AS THE ROOT CAUSE WAS IDENTIFIED IN A CAPA INVESTIGATION AS LIQUID INGRESS, SPECIFICALLY OF CLEANING SOLUTIONS AND RELATED DEBRIS, CAN CAUSE ERRATIC SETTINGS, INTERMITTENT OPERATION AND GENERAL ENCODER FAILURE BY CAUSING SHORTS IN THE ELECTRONIC COMPONENTS. THE BUTTON IS ALSO SUSCEPTIBLE TO CONTAMINATION AND SHORTS BY LIQUID INGRESS AND RELATED DEBRIS.

    Additional Manufacturer Narrative · 0

    B4:04AUG2021. IN ADDITION TO THE NAVIGATION RING NOT WORKING, THE CUSTOMER ALSO IDENTIFIED THE NAVIGATION RING BUTTON WAS BROKEN. THE CUSTOMER REPLACED THE NAVIGATION BUTTON TO RESOLVE THE ISSUE. THE UNIT WAS TESTED, AND IT WAS RETURNED TO SERVICE.

    Additional Manufacturer Narrative · 0

    B4:(B)(6) 2021. THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED FAILURE. THE (FSE) REPLACED THE FRONT BEZEL WITH NAVIGATION RING TO RESOLVE THE ISSUE. THE UNIT WAS TESTED, AND IT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE NAVIGATION RING DOES NOT WORK ANYMORE. THE CUSTOMER CAN NOT MAKE SETTING CHANGES VIA NAVIGATION RING, ONLY TOUCHSCREEN. THE DEVICE WAS NOT IN CLINICAL USE. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543986 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown