BEUDAMED
    FDA Adverse Event Other Summary report: N

    MILLENNIUM INFANT VENTILATOR

    MDR report key: 490830 · Received October 14, 2003

    Report

    Report Number
    2020676-2003-00002
    Event Type
    Other
    Date Received
    October 14, 2003
    Date of Event
    June 13, 2003
    Report Date
    October 14, 2003
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    VENTILATOR WAS IN USE WITH THE PT UNDERGOING BEDSIDE SURGICAL PROCEDURE WHEN LOSS OF POSITIVE EXPIRATORY END PRESSURE (PEEP) NOTICED. DOCTORS REPLACED VENTILATOR AND CONTINUED WITH PROCEDURE. NO HARM OR INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENNIUM INFANT VENTILATOR INFANT/PEDIATRIC VENTILATOR CBK SECHRIST INDUSTRIES, INC. MILLENNIUM *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other