BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE DATEX OHMEDA AVANCE

    MDR report key: 1100551 · Received August 5, 2008

    Report

    Report Number
    MW5007897
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    June 4, 2008
    Report Date
    July 21, 2008
    Manufacturer
    GE
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE INSPIRATORY LIMB OF ANESTHESIA CIRCUIT WAS OCCLUDED BY A STOPPER DEVICE THAT WAS LEFT ON INSPIRATORY PORT AFTER COMPLETING MACHINE CHECKOUT. THE STOPPER WAS ORIGINALLY INTENDED TO BE A TOOL USED BY CLINICAL ENGINEERING FOR MAINTENANCE OF ANESTHESIA MACHINES. THE STOPPER DEVICE SHOULD HAVE BEEN ALTERED FOR CLINICAL MACHINE CHECKOUT TO PREVENT AN ANESTHESIA CIRCUIT BEING PLACED ON THE OPPOSITE END. THE DEVICE SHOULD NEVER BE ABLE TO OCCLUDE AND CONNECT AN ANESTHESIA CIRCUIT AT THE SAME TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE DATEX OHMEDA AVANCE ANESTHESIA MACHINE BSZ GE ADVANCE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention