BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADULT CIRCUIT WITH EXPANDABLE TUBING

    MDR report key: 294903 · Received August 31, 2000

    Report

    Report Number
    2242551-2000-00016
    Event Type
    Other
    Date Received
    August 31, 2000
    Date of Event
    August 7, 2000
    Report Date
    August 31, 2000
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    CAI
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTS THAT THE HOSE GETS CRACKS 5 TO 10 INCHES FROM THE CUFF. ALSO, THE HEPA IS CRACKED AND CUFFS ARE COMING OFF. THE ELBOW STICKS IN THE FACE MASK AND IS DIFFICULT TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT CIRCUIT WITH EXPANDABLE TUBING ADULT CIRCUIT CAI VITAL SIGNS, INC. AXXXXX15 B160, A144

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other