BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3234035 · Received July 11, 2013

    Report

    Report Number
    3008355164-2013-00169
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 26, 2012
    Report Date
    June 26, 2013
    Manufacturer
    MAQUET CRITICAL CARE
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PT IT GENERATED TWO TECHNICAL ERROR CODES AND VENTILATION SUBSEQUENTLY STOPPED. ONE TECHNICAL ERROR CODE INDICATED DISABLED VALVES AND THE OTHER INDICATED AN INTERNAL MEMORY ERROR. THE VENTILATOR WAS REPLACED. THERE WAS NO PT HARM. IMPORTER REF #: (B)(4). REF # 8010042-2013-00107.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320660 SERVO-I CBK MAQUET CRITICAL CARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI