BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3110545 · Received April 5, 2013

    Report

    Report Number
    8010042-2013-00047
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER HAS BEEN ON SITE AND HAS STARTED THE INVESTIGATION. A SUPPLEMENTAL MDR REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139742 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1