BEUDAMED
    FDA Adverse Event Other Summary report: N

    BSM-6300A

    MDR report key: 5651447 · Received May 12, 2016

    Report

    Report Number
    2032233-2016-00255
    Event Type
    Other
    Date Received
    May 12, 2016
    Date of Event
    May 10, 2016
    Report Date
    June 9, 2016
    Manufacturer
    NIHON KOHDEN TOMIOKA CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921103517
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT BLOOD PRESSURE READINGS ARE DIFFERENT ON THE BEDSIDE MONITOR THAN WHEN USING THE MANUAL BLOOD PRESSURE CUFF. THE MANUAL BLOOD PRESSURE WAS PRODUCING A READING OF 178/62 WHERE AS THE BEDSIDE MONITOR WAS GIVING A READING OF 221/178. THE MANUAL CUFF BEING USED WAS A SMALL ADULT DURA CUFF. CUSTOMER WAS ASKED TO TEST USING THE NIHON KOHDEN CUFF, THE DURA CUFF, AND THROUGH THE BEDSIDE MONITOR TO COMPARE THE READINGS. AT PRESENT, THE CUSTOMER HAS NOT PURCHASED THE NIHON KOHDEN CUFF . NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BLOOD PRESSURE READINGS ARE DIFFERENT ON THE BEDSIDE MONITOR THAN WHEN USING THE MANUAL BLOOD PRESSURE CUFF. THE MANUAL BLOOD PRESSURE WAS PRODUCING A READING OF 178/62 WHERE AS THE BEDSIDE MONITOR WAS GIVING A READING OF 221/178. THE MANUAL CUFF BEING USED WAS A SMALL ADULT DURA CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307020 BSM-6300A VITAL SIGNS MONITOR MHX NIHON KOHDEN TOMIOKA CORPORATION BSM-6300A NA 04931921103517

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown