BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENERAL ANESTHESIA SYSTEMS

    MDR report key: 294890 · Received August 31, 2000

    Report

    Report Number
    2242551-2000-00014
    Event Type
    Other
    Date Received
    August 31, 2000
    Date of Event
    August 1, 2000
    Report Date
    August 30, 2000
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT AT LEAST SIX TO EIGHT CIRCUITS FROM THE B108 LOT NUMBER WERE DAMAGED ON THE HOSES. IT APPEARS THAT THE HOSES MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERAL ANESTHESIA SYSTEMS GENERAL ANESTHESIA CIRCUIT CAI VITAL SIGNS, INC. GXXXXX42 B108

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN