BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS (AMERICAN CONTRACT SYSTEMS)

    MDR report key: 492983 · Received October 17, 2003

    Report

    Report Number
    MW1029912
    Event Type
    Malfunction
    Date Received
    October 17, 2003
    Date of Event
    October 8, 2003
    Report Date
    October 13, 2003
    Manufacturer
    ACS
    Product Code
    LRP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TUBING COMES IN PACK TIGHTLY WOUND AND WHEN USED, IT KINKED, NOT ALLOWING ADEQUATE AIR FLOW. NEW TUBING WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS (AMERICAN CONTRACT SYSTEMS) INSUFFLATION TUBING FROM CUSTOM LAP CHOL PACK LRP ACS * 816031

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other