BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADULT CIRCUITS - GAS

    MDR report key: 315149 · Received January 30, 2001

    Report

    Report Number
    2242551-2001-00002
    Event Type
    Other
    Date Received
    January 30, 2001
    Date of Event
    January 4, 2001
    Report Date
    January 30, 2001
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTS THAT THIS WAS A SECOND INCIDENCE OF HOLE IN CIRCUIT. THE FIRST SAMPLE WAS NOT SAVED. SHIPPING BOX AND STOCK WERE CHECKED AND NO OTHER HOLES IN CIRCUITS OR BOXES. APPEARS TO BE MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3700 ADULT CIRCUITS - GAS GENERAL ANESTHESIA CIRCUIT CAI VITAL SIGNS, INC. GTSC0XGX B350

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other