BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 10210357 · Received June 29, 2020

    Report

    Report Number
    2031642-2020-02239
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Report Date
    November 18, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FAILURE ANALYSIS OF THE USER INTERFACE (UI) FRONT BEZEL ASSEMBLY SHOWS THAT THE NAV-RING POTENTIOMETER PRE-LOAD AND RESISTANCE MEASUREMENT TEST FAILED. CONTAMINATION BUILDUPS WERE FOUND ON THE ROTARY ADJUSTMENT ASSEMBLY (NAV-RING) MATRIX THAT CAUSED THE NAV-RING TO NOT FUNCTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2020. DATE OF REPORT: 29JUN2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NAV-RING IS NOT WORKING. THE FIELD SERVICE ENGINEER (FSE) VERIFIED THE REPORTED PROBLEM. THE FSE REPLACED THE FRONT BEZEL. THE CUSTOMER REPORTED THE UNIT WAS NOT IN USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674269 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown