BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSM-2351A

    MDR report key: 3952678 · Received July 11, 2014

    Report

    Report Number
    2080783-2014-00026
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    DRG
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT AFTER THE UNIT HAS BEEN POWERED ON FOR SOME TIME, THE SCREEN DEVELOPS HORIZONTAL WHITE LINES. MFR - 8030229-2014-00026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407958 BSM-2351A VITAL SIGN MONITOR DRG NIHON KOHDEN CORPORATION BSM-2341A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI