BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO VENTILATOR 300

    MDR report key: 1211303 · Received August 4, 2008

    Report

    Report Number
    1225700-2008-00121
    Event Type
    Malfunction
    Date Received
    August 4, 2008
    Report Date
    May 1, 2008
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT A PFT TECHNICAL ERROR CODE INDICATING A FAILED POWER TEST WAS GENERATED. IT WAS NOT POSSIBLE TO ADJUST PRESSURE GAINS.

    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 *