BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 1233803 · Received October 2, 2008

    Report

    Report Number
    1225700-2008-00177
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INITIAL BOOT UP THE VENTILATOR ALARMED AND DISPLAYED A TECHNICAL ERROR INDICATING A VOLTAGE ERROR. THE VENTILATOR WAS NOT CONNECTED TO PT AT THE TIME OF THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *