BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO VENTILATOR 300

    MDR report key: 969250 · Received December 21, 2007

    Report

    Report Number
    8010042-2007-00299
    Event Type
    Malfunction
    Date Received
    December 21, 2007
    Date of Event
    December 7, 2007
    Report Date
    December 7, 2007
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K970839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

    THE VENTILATOR WAS SWITCHED FROM "OFF" TO A VENTILATION MODE. AN UNUSUAL SMELL WAS DETECTED BY THE BIOMEDICAL ENGINEER. THE VENTILATOR WAS NOT BEING USED TO TREAT A PT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO VENTILATOR 300 CBK MAQUET CRITICAL CARE AB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR