BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE DATEX-OHMEDA AISYS CARESTATION

    MDR report key: 2925088 · Received November 26, 2012

    Report

    Report Number
    2925088
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 24, 2012
    Manufacturer
    GE DATEX-OHMEDA
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE, ANESTHESIA MACHINE ERROR OCCURRED TWICE PER ATTENDING SURGEON. PATIENT SUPPORTED WITH AMBU BAG WITH SUPPLEMENTAL O2. PROPOFOL GTT WAS INITIATED. MACHINE REPLACED WITH CONTINUOUS MONITORING USING PORTABLE DEVICE. PATIENT VSS THROUGHOUT SURGERY.ATTENDING SURGEON INDICATED THAT THIS PIECE OF EQUIPMENT WAS KNOWN TO HAVE HAD PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE DATEX-OHMEDA AISYS CARESTATION GAS-MACHINE, ANESTHESIA BSZ GE DATEX-OHMEDA AISYS CARESTATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR