BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSM-2354A

    MDR report key: 5801590 · Received July 17, 2016

    Report

    Report Number
    8030229-2016-00323
    Event Type
    Malfunction
    Date Received
    July 17, 2016
    Date of Event
    June 17, 2016
    Report Date
    June 17, 2016
    Manufacturer
    NIHON KOHDEN TOMIOKA CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K011918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTS THAT THE BSM (BEDSIDE MONITOR) SCREEN KEEPS GOING OUT AND THEN GOES WHITE. EVERY TIME THE DEVICE IS MOVED, THE SCREEN GOES OUT. THE DEVICE WAS RETURNED AND EVALUATED. THE CUSTOMER'S PROBLEM WAS DUPLICATED. THE INVERTER PC BOARD WAS REPLACED TO FIX THE ISSUE. THE BEDSIDE MONITOR WAS TESTED FOR A DAY. ALL STEPS IN THE MAINTENANCE CHECK SHEET WAS COMPLETED PER THE SERVICE MANUAL. THE REPAIRED DEVICE WAS RETURNED TO THE CUSTOMER. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTS THAT THE BSM (BEDSIDE MONITOR) SCREEN KEEPS GOING OUT AND THEN GOES WHITE. EVERY TIME THE DEVICE IS MOVED, THE SCREEN GOES OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454991 BSM-2354A VITAL SIGNS MONITOR MHX NIHON KOHDEN TOMIOKA CORPORATION BSM-2354A

    Patients

    Seq Age Sex Outcome Treatment
    1