BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 12086568 · Received June 29, 2021

    Report

    Report Number
    2031642-2021-04217
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 4, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPLACED FRONT BEZEL WAS RECEIVED FOR FAILURE INVESTIGATION (FI) BUT NO FI IS REQUIRED. PREVIOUS INVESTIGATIONS HAVE IDENTIFIED THAT LIQUID INGRESS, DUE TO THE VARIABILITY OF THE ASSEMBLY PROCESS, CAUSES NAVIGATION RING FAILURES.

    Additional Manufacturer Narrative · 0

    B4:06AUG2021. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND THE TOUCHSCREEN WAS RESPONDING. THE SE REPLACED THE FRONT BEZEL TO ADDRESS THE REPORTED ISSUE. THE UNIT WAS CHECKED OVERALL, RUN-IN TESTED, CLEANED, FUNCTIONALLY TESTED, AND NO ABNORMALITY WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR'S SETTINGS WERE JUMPING AROUND WHEN BEING CHANGED VIA THE NAVIGATION RING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981462 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown