BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAX-10

    MDR report key: 506252 · Received October 17, 2003

    Report

    Report Number
    506252
    Event Type
    Malfunction
    Date Received
    October 17, 2003
    Date of Event
    July 1, 2003
    Report Date
    August 1, 2003
    Manufacturer
    MAXTEC, INC.
    Product Code
    CCL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAX-10 OXYGEN SENSOR CELL CCL MAXTEC, INC. MAX-10 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other DELIVERY UNIT| DATEX MEDICAL INSTRUMENTATION AESTIVE ANESTHESIA