BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASIS

    MDR report key: 1061675 · Received June 3, 2008

    Report

    Report Number
    1061675
    Event Type
    Malfunction
    Date Received
    June 3, 2008
    Date of Event
    May 23, 2008
    Report Date
    June 3, 2008
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IN RESPIRATORY DISTRESS. THE TUBING ON THE COLLECTION DEVICE WAS FOUND TO BE BENT OVER AND KINKED. A CHEST X-RAY WAS ORDERED AND IT SHOWED A LEFT PNEUMOTHORAX. AFTER THE TUBING WAS UNKINKED THE CHEST X-RAY WAS OK.

    Description of Event or Problem · 1

    THE PATIENT WAS IN RESPIRATORY DISTRESS. THE TUBING ON THE COLLECTION DEVICE WAS FOUND TO BE BENT OVER AND KINKED. A CHEST X-RAY WAS ORDERED AND IT SHOWED A LEFT PNEUMOTHORAX. AFTER THE TUBING WAS UNKINKED THE CHEST X-RAY WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASIS CHEST DRAIN KDQ ATRIUM MEDICAL CORP. OASIS DRY SUCTION CHEST DRAIN *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR