BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6033521 · Received October 17, 2016

    Report

    Report Number
    2031642-2016-02738
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Report Date
    September 20, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE'S NO POWER TO UNIT, BATTERY CHARGE INDICATORS, OR MAINS INDICATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685042 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1