BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3121703 · Received May 8, 2013

    Report

    Report Number
    8010042-2013-00068
    Event Type
    Malfunction
    Date Received
    May 8, 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 FOUND THAT THE CONTROL CABLE FROM THE USER INTERFACE, WAS PULLED OUT OF THE PC1778 BOARD. BOTH THE CABLE AND PC BOARD WERE REPLACED. THE REPLACED PARTS HAVE BEEN REQUESTED FOR INVESTIGATION BUT NOT YET RECEIVED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202264 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1