BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEV-100

    MDR report key: 2254769 · Received September 13, 2011

    Report

    Report Number
    MW5022255
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    September 9, 2011
    Report Date
    September 13, 2011
    Manufacturer
    PHILLIPS RESPIRONICS
    Product Code
    BYT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEV 100 IS THE ONLY MACHINE IN AMERICA THAT CAN RUN DAUGHTER'S PORT-LUNG. IT IS CONSIDERED DISCONTINUED NOW. PHILIPS RESPIRONICS WILL NOT SHARE SCHEMATICS, OR PARTS. MACHINE IS BROKEN AND THEY WILL NOT REPAIR IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEV-100 NEGATIVE PRESSURE VENTILATOR BYT PHILLIPS RESPIRONICS 100 12-001

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Life Threatening