BEUDAMED
    FDA Adverse Event Other Summary report: N

    OXYGEN TENT CANOPY

    MDR report key: 512243 · Received February 20, 2004

    Report

    Report Number
    512243
    Event Type
    Other
    Date Received
    February 20, 2004
    Date of Event
    November 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    OHMEDA MEDICAL, PART OF GE MEDICAL SYSTEMS
    Product Code
    BYK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TENT SET-UP WAS IN PROGRESS. TENT CANOPY WAS DEFECTIVE; PRODUCT WAS TORN/CUT PRIOR TO ITS ARRIVAL AT THE HOSP. THE RT (RESPIRATORY THERAPIST) DOES NOT USE ANY SHARP INSTRUMENTS WHEN SETTING UP A TENT. THE OUTER PACKAGING DID NOT SHOW EVIDENCE OF BEING CUT OR TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYGEN TENT CANOPY CANOPY - PEDIATRIC AEROSOL BYK OHMEDA MEDICAL, PART OF GE MEDICAL SYSTEMS 2342/304-5061-300 20401

    Patients

    Seq Age Sex Outcome Treatment
    1 *