BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 925452 · Received March 30, 2007

    Report

    Report Number
    8010042-2007-00053
    Event Type
    Malfunction
    Date Received
    March 30, 2007
    Date of Event
    January 31, 2007
    Report Date
    March 27, 2007
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    k063404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT TWO ERROR CODES WERE GENERATED FROM THE VENTILATOR. ONE IMPLIES FAILED INTERNAL VOLTAGE SUPPLY AND THE OTHER AN OPEN SAFETY VALVE. THE VENTILATOR WAS NOT CONNECTED TO A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO-S CBK CBK MAQUET CRITICAL CARE AB 6640440 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *