BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO VENTILATOR 300

    MDR report key: 1222910 · Received August 14, 2008

    Report

    Report Number
    1225700-2008-00133
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 6, 2008
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR DURING TREATMENT BEGAN TO AUTO PEEP (POSITIVE END EXPIRATORY PRESSURE). THE PEEP INCREASED TO APPROX 30 CM H2O FROM SET 3 CM H2O. THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *