BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PU-681RA

    MDR report key: 22877826 · Received August 22, 2025

    Report

    Report Number
    8030229-2025-05334
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    August 7, 2025
    Report Date
    April 15, 2026
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THERE ARE SIGNIFICANT INCONSISTENT OR VARIABILITY IN MAP READINGS WITH EXTREME HEART RATES (E.G., 45 BPM OR 170 BPM). THEY NOTED INSTANCES WHERE PATIENTS HAD IDENTICAL BP READINGS, BUT THEIR MAPS DIFFERED BY AS MUCH AS 50 MMHG. THEY SHARED AN EXAMPLE OF A PATIENT WITH A HEART RATE OF 45 AND A BP OF 140/110, WHERE THE MAP FLUCTUATED BETWEEN 102 AND 52 ON TWO SEPARATE OCCASIONS. NO PATIENT HARM WAS REPORTED. INVESTIGATION CONCLUSION: ROOT CAUSE SUMMARY: WE CONFIRMED THE ISSUES NKC (NIHON KOHDEN CORPORATE) INVESTIGATE THE ISSUE AND THE DETAILS OF NKCS FINDINGS ARE EXPLAINED FURTHER BELOW, FOR REFERENCE. ·THE MOST LIKELY ROOT CAUSE OF THE REPORTED LARGE SHORT-TERM MAP FLUCTUATION IS INSTABILITY OF THE DETECTED PULSE WAVEFORM DURING NIBP MEASUREMENT, WHICH CAN OCCUR WHEN HEART RATE IS EXTREMELY HIGH OR LOW DUE TO ARRHYTHMIA OR SIMILAR PHYSIOLOGICAL CONDITIONS. AN UNSTABLE PULSE WAVEFORM CAN LEAD TO INACCURATE MAP CALCULATIONS, RESULTING IN APPARENT SHORT-TERM FLUCTUATIONS. ·CONTRIBUTING FACTORS THAT MAY CAUSE PULSE WAVEFORM INSTABILITY INCLUDE PATIENT-RELATED CONDITIONS (E.G., ARRHYTHMIA OR VASCULAR COMPLIANCE CHANGES), DEVICE-RELATED ISSUES (E.G., IMPROPER CUFF PLACEMENT OR CUFF DEGRADATION), AND EXTERNAL DISTURBANCES (E.G., BODY MOVEMENT OR VIBRATION DURING MEASUREMENT). · REVIEW OF ACTUAL NIBP MEASUREMENT DATA FROM THE AFFECTED DEVICE DID NOT REVEAL MAP FLUCTUATIONS COMPARABLE TO THE REPORTED EVENT (E.G., >30 MMHG WITHIN A SHORT PERIOD). IN CASES WHERE MODERATE SHORT-TERM MAP FLUCTUATIONS (>20 MMHG) WERE OBSERVED, THEY WERE ATTRIBUTED EITHER TO TRUE PHYSIOLOGICAL BLOOD PRESSURE VARIABILITY OR TO MEASUREMENT INACCURACY CAUSED BY UNSTABLE PULSE WAVEFORMS. · THE ISSUE HAS NOT RECURRED FOLLOWING A SOFTWARE UPDATE; HOWEVER, BECAUSE NO MAP CALCULATION CHANGES WERE MADE BETWEEN SOFTWARE VERSIONS 02-27 AND 02-29, SOFTWARE VERSION DIFFERENCES ARE NOT CONSIDERED A CONTRIBUTING FACTOR IN THIS CASE. CROSS REFERENCE NOTES: NKC INVESTIGATED SEPARATE EP LAB CONCERN ISSUES FOR THIS SAME FACILITY, (SIMILAR DEVICES, YET SEPARATE SERIAL NUMBERS), UNDER SEPARATE IRCS-589 (THIS TICKET (B)(6)) AND SEPARATE IRC-587 (TICKET (B)(6)), IRC-589 (TICKET (B)(6)), AND IRC-590 (TICKET (B)(6)). RESOLUTION NOTES: WE PROVIDED THE ABOVE EXPLANATION TO THE USER. SINCE EDUCATION WAS LAST PROVIDED NO FURTHER ISSUES RELATED TO THIS INCIDENT HAVE BEEN REPORTED TO DATE. ADDITIONAL DEVICE INFORMATION: THE FOLLOWING FIELD(S) CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED DUE TO THE CUSTOMER REQUESTING NOT TO BE CONTACTED. D10 CONCOMITANT MEDICAL DEVICE ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT, G3 DATE RECEIVED BY MANUFACTURER, G6 TYPE OF REPORT, H2 IF FOLLOW-UP, WHAT TYPE? H6 EVENT PROBLEM AND EVALUATION CODES, H11 ADDITIONAL MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THERE ARE SIGNIFICANT INCONSISTENT OR VARIABILITY IN MAP READINGS WITH EXTREME HEART RATES (E.G., 45 BPM OR 170 BPM). THEY NOTED INSTANCES WHERE PATIENTS HAD IDENTICAL BP READINGS, BUT THEIR MAPS DIFFERED BY AS MUCH AS 50 MMHG. THEY SHARED AN EXAMPLE OF A PATIENT WITH A HEART RATE OF 45 AND A BP OF 140/110, WHERE THE MAP FLUCTUATED BETWEEN 102 AND 52 ON TWO SEPARATE OCCASIONS. NO PATIENT HARM WAS REPORTED. 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 DEVICE INFORMATION: THE FOLLOWING FIELD(S) CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED DUE TO THE CUSTOMER REQUESTING NOT TO BE CONTACTED. D10 CONCOMITANT MEDICAL DEVICE.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THERE ARE SIGNIFICANT INCONSISTENT OR VARIABILITY IN MAP READINGS WITH EXTREME HEART RATES (E.G., 45 BPM OR 170 BPM). THEY NOTED INSTANCES WHERE PATIENTS HAD IDENTICAL BP READINGS, BUT THEIR MAPS DIFFERED BY AS MUCH AS 50 MMHG. THEY SHARED AN EXAMPLE OF A PATIENT WITH A HEART RATE OF 45 AND A BP OF 140/110, WHERE THE MAP FLUCTUATED BETWEEN 102 AND 52 ON TWO SEPARATE OCCASIONS. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THERE ARE SIGNIFICANT INCONSISTENT OR VARIABILITY IN MAP READINGS WITH EXTREME HEART RATES (E.G., 45 BPM OR 170 BPM). THEY NOTED INSTANCES WHERE PATIENTS HAD IDENTICAL BP READINGS, BUT THEIR MAPS DIFFERED BY AS MUCH AS 50 MMHG. THEY SHARED AN EXAMPLE OF A PATIENT WITH A HEART RATE OF 45 AND A BP OF 140/110, WHERE THE MAP FLUCTUATED BETWEEN 102 AND 52 ON TWO SEPARATE OCCASIONS. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433106 PU-681RA CENTRAL MONITORING SYSTEM MHX NIHON KOHDEN CORPORATION PU-681RA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown