BEUDAMED
    FDA Adverse Event Other Summary report: N

    VITAL SIGNS INC.

    MDR report key: 210198 · Received February 12, 1999

    Report

    Report Number
    2242551-1999-00002
    Event Type
    Other
    Date Received
    February 12, 1999
    Date of Event
    January 11, 1999
    Report Date
    February 12, 1999
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING INDUCTION OF ANESTHESIA THE PT'S MASK HAD NO AIR IN THE SEAL CREATING THE FOLLOWING: 1) INADEQUATE PADDING ON THE PT'S FACE WITH PRESSURE ON THE NOSE RESULTING IN A RED AREA ON NOSE. 2) INADEQUATE SEAL MADE IT IMPOSSIBLE TO VENTILATE THE PT AFTER INDUCTION OF ANESTHESIA - VALVE FOR INJECTING AIR FELL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL SIGNS INC. ADULT CIRCLE BREATHING CIRCUIT CAI VITAL SIGNS, INC. 5020EAM *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention