BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 5872864 · Received August 12, 2016

    Report

    Report Number
    2031642-2016-02016
    Event Type
    Malfunction
    Date Received
    August 12, 2016
    Report Date
    October 1, 2015
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING FAILURE INVESTIGATION ON THE RETURNED USER INTERFACE ASSEMBLY. THE FAILURE INVESTIGATION ENGINEER (FIE) FOUND THAT THE DISPLAY IS BLANK. THE (FIE) REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524062 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1