BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSM-1733A

    MDR report key: 9126426 · Received September 26, 2019

    Report

    Report Number
    8030229-2019-00497
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    September 3, 2019
    Report Date
    December 9, 2019
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921111833
    PMA / PMN Number
    K080342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT ON (B)(6) 2019, CUSTOMER AT (B)(6) HEALTH REPORTED THE BEDSIDE MONITOR (BSM-1733A SN: (B)(6)) NIBP WAS NOT FUNCTIONING PROPERLY. THE NIBP WAS REPORTED TO CONTINUOUSLY PUMP. CUSTOMER HAD TRIED SWITCHING THE HOSES, RESTARTING THE UNIT, UNPLUGGING AC POWER, AND TESTING ON A SIMULATOR. SERVICE REQUESTED : TROUBLESHOOTING/ASSISTANCE. SERVICE PERFORMED : THE REPORTED PROBLEM OF THE BSM NIBP IS NOT FUNCTIONING PROPERLY WAS NOT DUPLICATED. OUR EVALUATION FOUND THERE WAS PHYSICAL DAMAGE ON FRONT ENCLOSURE AND BATTERY COMPARTMENT THAT MADE POWER SWITCH WORKING INTERMITTENTLY. DAMAGED PICTURES UPLOADED IN NOTIFICATION FOLDER (B)(4). THE UNIT NEEDS TO UPGRADE SPO2 FIRMWARE FROM VER 5.0.0.5 TO VER 5.2.0.1 CUSTOMER DECLINED TO REPLACE FRONT AND REAR ENCLOSURE. FOR PRECAUTIONARY MEASURE REPLACED NIBP VALVE. AND UPGRADED A/MS-2013 MASIMO BOARD VER 5.2.0.1 (WARRANTY) 923119 SOLENOID FOR ONE CONNECTOR (WARRANTY) THE UNIT WAS TESTED PER THE OPERATOR'S/SERVICE MANUAL AND THE RESULTS WERE RECORDED ON THE ATTACHED MAINTENANCE CHECK SHEET. THE UNIT COMPLETED 24 HOURS OF EXTENDED TESTING AND OPERATES TO THE MANUFACTURER'S SPECIFICATIONS. INVESTIGATION RESULT THE DEVICE WARRANTY BEGAN 04/14/16. REVIEW OF DEVICE C4C HISTORY FOUND NO PREVIOUSLY REPORTED ISSUES WITH THE UNIT. NKA EVALUATION WAS UNABLE TO DUPLICATE THE REPORTED ISSUE OF NIBP NOT FUNCTIONING PROPERLY. EVALUATION FOUND UNIT TO HAVE SIGNS OF PHYSICAL DAMAGE. AS A PRECAUTIONARY MEASURE, THE NIBP VALVE AND SOLENOID WAS REPLACED. UNIT WAS TESTED TO OPERATE WITHIN SPECIFICATIONS AFTER REPAIR. APPROXIMATE AGE OF THE UNIT WAS 3 YEARS. UNIT WAS FOUND TO HAVE PHYSICAL DAMAGE. AS EVALUATION WAS UNABLE TO DUPLICATE THE REPORTED ISSUE, THE ROOT CAUSE COULD NOT BE DETERMINED. UNIT HAS NO TREND OF NIBP ISSUES. INVESTIGATION CONCLUSION: APPROXIMATE AGE OF THE UNIT WAS 3 YEARS. UNIT WAS FOUND TO HAVE PHYSICAL DAMAGE. AS EVALUATION WAS UNABLE TO DUPLICATE THE REPORTED ISSUE, THE ROOT CAUSE COULD NOT BE DETERMINED. UNIT HAS NO TREND OF NIBP ISSUES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE NIBP COMPONENT ON THE BEDSIDE MONITOR (BSM) WAS CONTINUOUSLY PUMPING WITHOUT PROVIDING A READING.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE NIBP COMPONENT ON THE BEDSIDE MONITOR (BSM) WAS CONTINUOUSLY PUMPING WITHOUT PROVIDING A READING. THE CUSTOMER ALSO REPORTED THAT THEY HAD TRIED USING DIFFERENT HOSES, RESTARTING THE UNIT, UNPLUGGING AND PLUGGING THE AC POWER, AS WELL AS DOING TESTING ON A SIMULATOR, BUT THE ISSUE STILL PERSISTS. THE CUSTOMER SENT THE UNIT IN FOR REPAIR AND IT IS CURRENTLY AWAITING EVALUATION. 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 THE NIBP COMPONENT ON THE BEDSIDE MONITOR (BSM) WAS CONTINUOUSLY PUMPING WITHOUT PROVIDING A READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918065 BSM-1733A VITAL SIGNS MONITOR MHX NIHON KOHDEN CORPORATION BSM-1733A NA 04931921111833

    Patients

    Seq Age Sex Outcome Treatment
    1