BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BSM-1753A

    MDR report key: 8903838 · Received August 16, 2019

    Report

    Report Number
    8030229-2019-00387
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    July 25, 2019
    Report Date
    December 10, 2019
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921111871
    PMA / PMN Number
    K080342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: ON (B)(6) 2019 CUSTOMER STATED TRANSPORT MONITOR WAS EXPERIENCING CHECK LEADS ERROR. CUSTOMER HAD TESTED DEVICE WITH NEW LEAD SETS. THE ISSUE OCCURS WHEN THE LEADS ARE MOVED. DEVICE WAS SENT TO NKA FOR REPAIRS. THE REPORTED ISSUE WAS DUPLICATED. WHEN TRANSPORT MONITOR WAS DOCKED INTO A BSM-6000 SERIES, TWO ERROR MESSAGES WERE DISPLAYED: "NIBP MODULE ERROR" AND "NIBP CONNECTOR OFF". ADDITIONALLY, NOISE ON THE ECG WAVEFORM WAS NOTED. ECG BOARD (UR-4250), PUMP ASSEMBLY (9000057903) AND SOLENOID VALVE (923119) WERE REPLACED TO RESOLVE THE ISSUE. SERVICE REQUESTED: REPAIR. SERVICE PERFORMED: REPAIR. INVESTIGATION RESULT: THE ECG BOARD (UR-4250) CONTAINED AN ECG CONNECTOR AND THE CIRCUIT BOARD. BY REPLACING THIS COMPONENT CONTAINING THE ECG CONNECTOR, IT RESOLVED THE ISSUE OF "CHECK LEAD ERROR" WHEN THE LEAD SET IS MOVED. THE PUMP ASSEMBLY (9000057903) AND SOLENOID VALVE (923119) WERE REPLACED TO RESOLVE THE NIBP ISSUE. TRENDING FOR EACH PART ARE AS FOLLOWS. ECG BOARD: 28 INCIDENTS SINCE (B)(6) 2015 WITH A PRIOR INCIDENT OCCURRED ON (B)(6) 2018. NONE OTHER HAS OCCURRED IN 2019. THERE IS CURRENTLY NO TREND FOR ECG BOARD FAILURE. PUMP ASSEMBLY: 154 INCIDENTS SINCE (B)(6) 2015. SOLENOID VALVE: 133 INCIDENTS SINCE (B)(6) 2015. THE PUMP AND SOLENOID ASSEMBLY FAILURES ARE BEING INVESTIGATED UNDER IRC-NKA300155567. THE INVESTIGATION IS CURRENTLY IN PROGRESS. DEVICE WAS PUT INTO SERVICE ON 3/30/2017. SERVICE HISTORY FOR THIS DEVICE SHOWS THIS IS AN ISOLATED ISSUE. ALTHOUGH THE ROOT CAUSE OF THE ECG BOARD/CONNECTOR FAILURE WAS NOT KNOWN, THERE IS CURRENTLY NO TREND ON THIS ISSUE. THE INVESTIGATION INTO THE NIBP ISSUE IS BEING CONDUCTED UNDER IRC-NKA300155567. INVESTIGATION CONCLUSION: ALTHOUGH THE ROOT CAUSE OF THE ECG BOARD/CONNECTOR FAILURE WAS NOT KNOWN, THERE IS CURRENTLY NO TREND ON THIS ISSUE. THE INVESTIGATION INTO THE NIBP ISSUE IS BEING CONDUCTED UNDER IRC-NKA300155567. THE FOLLOWING FIELDS ARE NOT APPLICABLE (N/A) TO THIS REPORT: A2 - A6 B2 B6 B7 D4 LOT # & EXPIRATION DATE D6 - D7 D9 D11 & C2 F10 G6 G8 H7 H9 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? H3. DEVICE EVALUATED BY MANUFACTURER H6. EVENT PROBLEM AND EVALUATION CODES H10. ADDITIONAL MANUFACTURER NARRATIVE

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE BEDSIDE MONITOR (BSM) DISPLAYED A "CHECK LEADS" ERROR MESSAGE AND WAVE FORMS DROPPED OUT WHILE MONITORING PATIENT. NO CONSEQUENCE OR IMPACT TO THE PATIENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE BEDSIDE MONITOR (BSM) DISPLAYED A "CHECK LEADS" ERROR MESSAGE AND WAVE FORMS DROPPED OUT WHILE MONITORING PATIENT. NO CONSEQUENCE OR IMPACT TO THE PATIENT WAS REPORTED. THE DEVICE WAS RETURNED TO NIHON KOHDEN AND IS 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 BEDSIDE MONITOR (BSM) DISPLAYED A "CHECK LEADS" ERROR MESSAGE AND WAVE FORMS DROPPED OUT WHILE MONITORING PATIENT. NO CONSEQUENCE OR IMPACT TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697052 BSM-1753A VITAL SIGNS MONITOR MHX NIHON KOHDEN CORPORATION BSM-1753A NA 04931921111871

    Patients

    Seq Age Sex Outcome Treatment
    1