BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADULT CIRCLE BREATHING CIRCUIT W/INTERNAL GAS SAMPLING

    MDR report key: 154739 · Received March 4, 1998

    Report

    Report Number
    2242551-1998-00005
    Event Type
    Other
    Date Received
    March 4, 1998
    Date of Event
    February 2, 1998
    Report Date
    February 2, 1998
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    CAI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GAS SAMPLE LINE WAS MISSING WHEN THEY WERE SETTING UP ROOM, AT THE CUFF, AFTER THE CAP (LOT #006D). GAS SAMPLE LINE CAME OFF AT THE CUFF AFTER THE LUER CAP DURING A CASE BY DR. (LOR#UNK). THE HOSE HAS HOLES IN THE EXPIRATORY SIDE (LOR#UNK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT CIRCLE BREATHING CIRCUIT W/INTERNAL GAS SAMPLING ADULT BREATHING CIRCUIT WITH INTERNAL GAS CAI VITAL SIGNS, INC. NA 006D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other