BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 1093503 · Received April 16, 2008

    Report

    Report Number
    1225700-2008-00054
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 19, 2008
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED THE INTERNAL LEAKAGE, AND FLOW TRANSDUCER TEST DURING THE PRE-USE CHECK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *