BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSM-1733A

    MDR report key: 7675164 · Received July 10, 2018

    Report

    Report Number
    8030229-2018-00258
    Event Type
    Malfunction
    Date Received
    July 10, 2018
    Date of Event
    June 12, 2018
    Report Date
    October 24, 2019
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921111833
    PMA / PMN Number
    K080342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT ON 06/12/18, CUSTOMER AT ST. ELIZABETH'S HOSPITAL REPORTED THE BEDSIDE MONITOR (BSM-1733A SN:(B)(4) ) WAS GETTING AN ERROR AND INCORRECT READINGS FROM THE PUMP. SERVICE REQUESTED REPAIR. SERVICE PERFORMED THE UNIT WAS CLEANED AND EVALUATED. THE REPORTED PROBLEM OF "INCORRECT READING WITH NIBP" WAS DUPLICATED. REPLACED THE SOLENOID, NIBP SOCKET AND THE PUMP TO RESOLVE THE ISSUE. THE UNIT COMPLETED 3 DAYS OF EXTENDED TESTING AND OPERATES TO MANUFACTURER'S SPECIFICATIONS. COMPLETE ALL STEPS IN THE MAINTENANCE CHECK SHEET PER THE SERVICE MANUAL. INVESTIGATION RESULTS PER NKC DHR, THE UNIT 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. THE DEVICE WARRANTY BEGAN 04/30/17. THE ISSUE WAS REPORTED AFTER 13 MONTHS AT CUSTOMER FACILITY. REVIEW OF DEVICE SAP HISTORY FOUND NO PREVIOUSLY REPORTED ISSUES WITH THE UNIT. SIMILAR TICKETS REVIEW USING THE FOLLOWING KEYWORDS FOUND THE FOLLOWING RELATED ISSUES: "NIBP INCORRECT" (1) 30198 REPORTED AT CANON MEDICAL SYSTEMS FOR BSM-2351A SN:(B)(4) AGE OF UNIT: 11 YEARS. CUSTOMER DISCONTINUED USE OF PRODUCT. "NIBP INACCURATE" (2) 32154 REPORTED AT WINTHROP UNIVERSITY HOSPITAL FOR AY-653P-QM SN: (B)(4) AGE OF UNIT: 3 YEARS (3) 24198 REPORTED AT PULASKI MEMORIAL HOSPITAL FOR MU-631RA SN: (B)(4) AGE OF UNIT: 5 YEARS "NIBP LOW" 55405 REPORTED AT VIDANT MEDICAL CENTER FOR BSM-1733A SN:(B)(4) AGE OF UNIT: 2 YEARS "NIBP HIGH" 19602 REPORTED AT CRAWFORD MEMORIAL HOSPITAL FOR AY-671P-QM SN: 472; AGE OF UNIT: <3 MONTHS. ISSUE COULD NOT BE DUPLICATED AT NKA. "BP INACCURATE" (4) 38509 REPORTED AT ABBOTT NORTHWESTERN HOSPITAL FOR CU-192RA SN:571. ROOT CAUSE: IMPROPER USE OF NK EQUIPMENT (5) 60228 REPORTED AT WINTHROP UNIVERSITY HOSPITAL FOR AY-653P-QM SN:(B)(4). ROOT CAUSE UNDETERMINED. "BP WRONG/HIGH/LOW" "NIBP WRONG" "BLOOD PRESSURE INCORRECT/WRONG/INACCURATE/HIGH/LOW" NONE RELATED FROM THE RESULTS ABOVE, PRODUCT BSM-1733A HAS NO TENDENCY OF ISSUES WITH INACCURATE NIBP READINGS. UNIT HAS NO PRIOR HISTORY OF NIBP ISSUES. THE BSM WAS ABLE TO NOTIFY USER OF ISSUE WITH ERROR. ISSUE WAS RESOLVED THROUGH SERVICING AND WAS TESTED TO OPERATE WITHIN SPECIFICATIONS AFTER REPAIR. CONDITION OF THE UNIT WAS NOT NOTED. THE ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE HOWEVER NO ADVERSE TREND HAS BEEN FOUND. THE REPAIRED UNIT WAS RETURNED TO THE CUSTOMER ON 07/13/18 AND THERE WERE NO FURTHER REPORTED ISSUES WITH THE UNIT. THIS ISSUE IS NOT SUSPECTED TO BE CAUSED BY DEFICIENT DEVICE DESIGN.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER REPORTED THAT THE NIBP MODULE ON THE BEDSIDE MONITOR (BSM) WAS GIVING INCORRECT READINGS.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE NIBP MODULE ON THE BEDSIDE MONITOR (BSM) WAS GIVING INCORRECT READINGS. NO PATIENT HARM WAS REPORTED. THEY SENT THE DEVICE 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 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE NIBP MODULE ON THE BEDSIDE MONITOR (BSM) WAS GIVING INCORRECT READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514706 BSM-1733A VITAL SIGNS MONITOR MHX NIHON KOHDEN CORPORATION BSM-1733A N/A 04931921111833

    Patients

    Seq Age Sex Outcome Treatment
    1