BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSM-6300A

    MDR report key: 5716320 · Received June 9, 2016

    Report

    Report Number
    8030229-2016-00255
    Event Type
    Malfunction
    Date Received
    June 9, 2016
    Date of Event
    May 10, 2016
    Report Date
    May 10, 2016
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K080342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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.

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE: 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. THE REPORTED EVENT REGARDING BLOOD PRESSURE READINGS ARE DIFFERENT FROM THE MANUAL BLOOD PRESSURE CUFF WAS CONFIRMED. HOWEVER, THE MALFUNCTION OF THE DEVICE WAS DUE TO THE USE OF A CUFF BRAND THAT IS NOT RECOMMENDED BY THE NIHON KOHDEN (NK) DEVICE MANUAL. THEREFORE, PRODUCT DEFICIENCY WAS NOT IDENTIFIED. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR PART 803.56 IF 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
    370034 BSM-6300A VITAL SIGNS MONITOR MHX NIHON KOHDEN CORPORATION BSM-6300A

    Patients

    Seq Age Sex Outcome Treatment
    1