BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSM-6300A

    MDR report key: 7975574 · Received October 17, 2018

    Report

    Report Number
    8030229-2018-00402
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Date of Event
    September 20, 2018
    Report Date
    January 10, 2020
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921103517
    PMA / PMN Number
    K080342
    Removal / Correction Number
    NOT APPLICABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT. CUSTOMER REPORTED AN ISSUE AT SOUTHERN NEW HAMPSHIRE MED CTR IN WHICH NURSES REPORTED THE BSM-6300 UNITS WERE SHOWING NIBP READINGS THAT WERE 20-30 POINTS HIGHER THAN WHAT THEY WERE EXPECTING/READING FROM THEIR PHILIPS MONITORS. SERVICE REQUESTED/PERFORMED NKA CLINICAL APPLICATION SPECIALIST (CAS) TEAM WENT ONSITE AND RAN MULTIPLE NIBP TESTS ON MULTIPLE MONITORS, USING MULTIPLE PEOPLE AND MULTIPLE CUFFS. THE NIBP READING WAS CONFIRMED TO BE CONSISTENTLY READING 20-30 POINTS HIGHER. INVESTIGATION RESULT PER NKC DHR (ATTACHED), THE DEVICE IN QUESTION (MU-631RA SN: (B)(6)) HAS HAD NO HISTORY OF NCMR, DEVIATION, OR CAPA DURING MANUFACTURING OF THE DEVICE. THE DEVICE HAS NOT BEEN REFURBISHED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS BEFORE DEVICE RELEASE THAT MIGHT RELATE TO THE REPORTED ISSUE. REVIEW OF THE DEVICE C4C HISTORY FOUND NO OTHER ISSUES REPORTED FOR THIS UNIT AFTER RELEASE TO THE CUSTOMER. THE ISSUE OF HIGH NIBP READINGS WAS NOT REPORTED AGAINST A SPECIFIC UNIT BUT FOR SEVERAL UNITS OF THE BSM-6300A MODEL AT THE FACILITY. REVIEW OF TICKETS OPENED AT (B)(6) MED CTR REVEALED THE FOLLOWING CREATED FOR THE BSM-6300A (MU-6X1RA) MODEL: ID CREATED ON PRODUCT ID DESCRIPTION : 39672 09/19/2018 12:41 PM MU-671RA ERROR: GAS DEVICE ERROR; 39738 09/20/2018 08:13 AM MU-631RA NK VS. PHILIPS BP READINGS ; 41711 10/15/2018 12:20 PM MU-671RA ART NOT SHOWING IN TREND; 42189 10/19/2018 07:03 AM MU-631RA IP FOR BSM IN BIRTHPLACE; 53286 03/06/2019 08:22 PM MU-631RA ASYSTOLE ALARM KEEPS ALARMING; 53667 03/12/2019 10:43 AM MU-651RA DEFAULTS TO ADULT NIBP; 54970 03/28/2019 02:23 AM MU-671RA 100% AV PACED ALL THE TIME; 55969 04/10/2019 05:11 AM MU-631RA WATCH DOG ERROR; 56430 04/12/2019 12:19 PM MU-671RA ENABLE SYNC SOUND PERMANENTLY; 69140 09/25/2019 11:12 AM MU-631RA MICROPOD WILL NOT TAKE READINGS; 70228 10/11/2019 10:48 AM MU-631RA DISPLAY IS GREEN COLOR; 67075 08/27/2019 11:48 AM MU-631RA WHITE LINES ON DISPLAY. 69159 09/25/2019 01:04 PM MU-671RA MU-671RA TREND TABLE NOT POPULATING (TRB). ASIDE FROM THE CURRENT TICKET ((B)(4)), THE ABOVE INCIDENTS WERE REPORTED FOR ISSUES NOT RELATING TO HIGH NIBP READINGS. FACTORS WHICH CAN CAUSE INACCURATE NIBP READINGS INCLUDE: BP CUFF SIZE, CUFF PLACEMENT, PERFUSION, HEART RHYTHM, OR THE USE OF ADAPTERS (CUSTOMERS HAVE BEEN FOUND TO CUT THE BP HOSE AND ATTACH AN ADAPTER IN ORDER TO CONTINUE TO USE THEIR CURRENT BP CUFFS). THE LATTER IS AGAINST MANUFACTURER'S RECOMMENDATIONS AS CUTTING THE BP HOSE TUBING, ALONG WITH USE OF NON-NK APPROVED/TESTED BP CUFFS, CAN AFFECT ACCURACY OF THE BP READINGS. THE DEFAULT NK METHOD OF NIBP AND MAP CALCULATION IS OCCLUSIVE-OSCILLOMETRIC METHOD TO MEASURE SYSTOLIC, DIASTOLIC AND MEAN ARTERIAL NON-INVASIVE BLOOD PRESSURE (NIBP). HOWEVER, CLINICIANS AND PROVIDERS MAY ONLY BE AWARE OF THE CALCULATED METHOD AND THEREFORE PERCEIVE THE OCCLUSIVE-OSCILLOMETRIC METHOD TO BE INACCURATE. THIS OFTEN OCCURS WITH CONVERSIONS FROM OTHER PATIENT MONITORING VENDORS TO NK. FURTHER INVESTIGATION OF THE ISSUE IS LIMITED AS NO BSM-6300A UNIT WAS RETURNED TO NKA FOR EVALUATION. BASED ON THE METHOD OF BLOOD PRESSURE CALCULATION, THE DEVICE MAY HAVE PROVIDED A DIFFERENT BLOOD PRESSURE RESULT THAN WAS EXPECTED BY THE END-USER. THE USER WAS COMPARING THE NIBP VALUES TO THOSE FROM ANOTHER VENDOR (PHILIPS). WHAT IS NOT KNOWN IS THE METHOD OF CALCULATION THE PHILLIPS DEVICES WERE USING, OR IF THE CUFF WAS PROPERLY PLACED AND SIZED. IN ADDITION, WITH CUSTOMERS "TESTING" NIBP DIFFERENCE ON PATIENTS, THERE IS NO WAY TO DETERMINE WHICH, IF ANY, DEVICE WAS PROVIDING INACCURATE BLOOD PRESSURE. USE OF A VALIDATED SIMULATOR PROVIDES A MORE ACCURATE MEANS OF TESTING THE DEVICE'S NIBP READING. IN THE ABSENCE OF INFORMATION AND THE ABILITY TO ASSESS THE DEVICE, THE ROOT CAUSE COULD NOT BE DETERMINED. NO ADVERSE TREND IS SUSPECTED AS REVIEW OF TICKETS OPENED AT CUSTOMER FACILITY FOUND NO OTHER INCIDENTS OF HIGH NIBP READINGS FOR THE BSM-6300 MODEL. INVESTIGATION CONCLUSION. IN THE ABSENCE OF INFORMATION AND THE ABILITY TO ASSESS THE DEVICE, THE ROOT CAUSE COULD NOT BE DETERMINED. NO ADVERSE TREND IS SUSPECTED AS REVIEW OF TICKETS OPENED AT CUSTOMER FACILITY FOUND NO OTHER INCIDENTS OF HIGH NIBP READINGS FOR THE BSM-6300 MODEL. ADDITIONAL INFORMATION: B4. DATE OF THIS REPORT; F6. DATE USER FACILITY/IMPORTER BECAME AWARE OF THE EVENT; F7. TYPE OF REPORT; F11. DATE REPORT SENT TO FDA; F13. DATE REPORT SENT TO MANUFACTURER; G4. DATE RECEIVED BY MANUFACTURER; G7. TYPE OF REPORT; H2. IF FOLLOW-UP, WHAT TYPE? ; ADDITIONAL INFORMATION ; H6. EVENT PROBLEM AND EVALUATION CODES; H10. ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BSM PROVIDED A HIGH BLOOD PRESSURE READINGS THAN THE EXPECTED READING. NO CONSEQUENCE OR IMPACT TO PATIENT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE BEDSIDE MONITORING DEVICE (BSM) PROVIDED A HIGH BLOOD PRESSURE READINGS THAN THE EXPECTED READING. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. 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

    IT WAS REPORTED THAT THE BSM PROVIDED A HIGH BLOOD PRESSURE READINGS THAN THE EXPECTED READING. NO CONSEQUENCE OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814582 BSM-6300A VITAL SIGNS MONITOR MHX NIHON KOHDEN CORPORATION BSM-6300A NOT APPLICABLE 04931921103517

    Patients

    Seq Age Sex Outcome Treatment
    1