BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE HEALTHCARE COMPANY, NEONATAL ANESTHESIA CIRCUIT

    MDR report key: 3281846 · Received August 7, 2013

    Report

    Report Number
    MW5031362
    Event Type
    Injury
    Date Received
    August 7, 2013
    Date of Event
    July 24, 2013
    Report Date
    August 6, 2013
    Manufacturer
    VITAL SIGNS, INC
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING INHALATION INDUCTION, (B)(6) DESATURATED. AMBU BAG VENTILATION INITIATED, ANESTHESIA REMOVED INSPIRATORY CIRCUIT AT THE ATTACHMENT POINT ON THE ANESTHESIA MACHINE AND FOUND A BLUE PLASTIC CAP BLOCKING THE FLOW TO THE PT OF OXYGEN AND ANESTHESIA. BLUE CAP BELIEVED TO HAVE COME ON NEW CIRCUIT OPENED FOR THIS CASE. THE ANESTHESIA MACHINE WAS USED ON PREVIOUS CASE AND AFTER THIS CASE WITHOUT INCIDENT. REASON FOR USE: DISPOSABLE ANESTHESIA CIRCUIT USED FOR THE DELIVERY OF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372522 GE HEALTHCARE COMPANY, NEONATAL ANESTHESIA CIRCUIT NEONATAL ANESTHESIA CIRCUIT CAI VITAL SIGNS, INC 1552016 6270A

    Patients

    Seq Age Sex Outcome Treatment
    1 14 MO Required Intervention