BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO-I

    MDR report key: 934199 · Received October 26, 2007

    Report

    Report Number
    8010042-2007-00240
    Event Type
    Death
    Date Received
    October 26, 2007
    Date of Event
    October 5, 2007
    Report Date
    October 16, 2007
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K063404
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY MAQUET CRITICAL CARE. MAQUET CRITICAL CARE PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATION STOPPED, WHILE IT WAS CONNECTED TO A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death