BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 695473 · Received October 12, 2005

    Report

    Report Number
    2518435-2005-00007
    Event Type
    Malfunction
    Date Received
    October 12, 2005
    Date of Event
    October 5, 2005
    Report Date
    October 12, 2005
    Manufacturer
    SCOTT MEDICAL PRODUCTS
    Product Code
    BXK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SCOTT MEDICAL PRODUCTS PRODUCES CALIBRATION GAS MIXTURES IN AEROSOL STYLE CYLINDERS (7 INCHES TALL X 2.5 INCHES IN DIAMETER HOLDING 4 LITERS OF GAS) FOR DATEX-OHMEDA. THE BUYER FROM DATEX-OHMEDA REPORTED THAT THE CYLINDER VALVE SEPARATED FROM THE CYLINDER FROM A RECENT SHIPMENT RELEASING THE GAS. THE CYLINDER WAS SITTING ON A STORAGE SHELF WHEN THE VALVE RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA CALIBRATION GAS BXK SCOTT MEDICAL PRODUCTS NA 527201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA