BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO S

    MDR report key: 969756 · Received December 21, 2007

    Report

    Report Number
    8010042-2007-00295
    Event Type
    Death
    Date Received
    December 21, 2007
    Date of Event
    December 9, 2007
    Report Date
    December 21, 2007
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K041223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SALES COMPANY PERFORMED A PRE-USE CHECK AND A FUNCTION CHECK OF THE VENTILATOR. ALL RESULTS WERE NORMAL. 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 THERE WAS NO VENTILATING SOUND FROM THE VENTILATOR. THE VENTILATOR WAS ALARMING AND THE GENERATED ALARM COULD NOT BE SILENCED. THE PATIENT TUBE WAS REMOVED AND MANUAL VENTILATION WAS PERFORMED. THE PATIENT EXPIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death