BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 7157534 · Received January 2, 2018

    Report

    Report Number
    2031642-2018-00006
    Event Type
    Malfunction
    Date Received
    January 2, 2018
    Report Date
    December 12, 2017
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE: 12/13/2011.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WOULD NOT RUN ON ALTERNATING CURRENT (AC). THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1