BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 3234023 · Received July 11, 2013

    Report

    Report Number
    3008355164-2013-00168
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    July 1, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR INDICATING A CONTROL PRINTED CIRCUIT BOARD FAILURE DURING INSTALLATION. THERE WAS NO PT INVOLVEMENT. IMPORTER REF #: (B)(4). REF # 8010042-2013-00106.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321171 SERVO-S CBK MAQUET CRITICAL CARE AB 6640440 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA