BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 1912479 · Received November 23, 2010

    Report

    Report Number
    8010042-2010-00263
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    June 17, 2010
    Report Date
    June 17, 2010
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR GENERATED TWO TECHNICAL ERROR CODES INDICATING DISABLED VALVES AND A CONTROL PRINTED CIRCUIT BOARD COMMUNICATION FAILURE WITH THE MONITORING PRINTED CIRCUIT BOARD. (B)(4).

    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