BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERAL ELECTRIC

    MDR report key: 1972643 · Received January 24, 2011

    Report

    Report Number
    MW5019130
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 24, 2011
    Manufacturer
    GENERAL ELECTRIC
    Product Code
    CBR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING PROCESS TO ADMINISTER ANESTHESIA GAS TO INTUBATED PT, IT WAS NOTED THAT THE ANESTHESIA MACHINE -AISYS 5/GE- WOULD NOT ADMINISTER THE AGENT. THE SAFETY PROGRAM HAD BEEN UPDATED/INSTALLED THE EVENING PRIOR TO THIS EVENT WITHOUT ANY INDICATION THAT AGENTS WOULD NOT TURN ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERAL ELECTRIC AISYS 5 CBR GENERAL ELECTRIC AISYS 5

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Disability