BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE HEALTHCARE

    MDR report key: 1590960 · Received January 27, 2010

    Report

    Report Number
    MW5014571
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Date of Event
    October 22, 2009
    Report Date
    January 27, 2010
    Manufacturer
    GE HEALTHCARE
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WE, AS A FACILITY, HAD 11 DATEX/OMEDA ADU-98 ANESTHESIA MACHINES SOFTWARE UPGRADE WHICH INCLUDE SOME NEW CAPABILITIES. WHEN SERVICE REPORT WAS PROVIDED TO US, IT WAS DONE ALL UNDER 1 SERIAL NUMBER. FOR THE MFR TO DOCUMENT THE QA PROCESS OF THE FDA, I WAS EXPECTING ONE FOR EACH UNIT. FEEL MFR -GE HEALTHCARE- IS NOT FOLLOWING THE EXPECTED QA PROCESS OF FDA IN REGARDS TO MEDICAL EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE HEALTHCARE ANESTHESIA DELIVERY UNIT BSZ GE HEALTHCARE ADU-98

    Patients

    Seq Age Sex Outcome Treatment
    1