BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON - INVASIVE VENTILATOR

    MDR report key: 6128643 · Received November 23, 2016

    Report

    Report Number
    MW5066336
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 23, 2016
    Manufacturer
    PHILLIPS RESPIRONICS
    Product Code
    MNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NON-INVASIVE VENTILATOR WAS UNPLUGGED IN ORDER TO TRANSPORT PT FROM HIS HOSPITAL ROOM TO CT SCAN. ONCE OUT IN HALLWAY, UNIT SHUT OFF. PT WAS RETURNED TO HIS ROOM AND UNIT WAS PLUGGED IN. RESPIRATORY THERAPY STAFF ATTEMPTED TO RESTART UNIT BUT IT WOULD NOT RESTART. PT WAS THEN PLACED ON NON-REBREATHER MASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774900 NON - INVASIVE VENTILATOR NON-INVASIVE VENTILATOR MNT PHILLIPS RESPIRONICS V 60

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR