BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PU-681RA

    MDR report key: 21632494 · Received March 18, 2025

    Report

    Report Number
    8030229-2025-04740
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    February 23, 2025
    Report Date
    June 5, 2025
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) KEEPS LOSING THE VITAL SIGNS ON THE PATIENT; THE VITAL SIGNS GOES AWAY THEN THEY COME BACK AND IT DOES NOT SHOW THE HEART RHYTHM, JUST THE HEARTBEAT. BME REMOVED AND REPLACED THE CNS. 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 Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) KEPT LOSING THE PATIENT'S VITAL SIGNS. THE VITAL SIGNS WOULD GO AWAY THEN COME BACK AND WOULD NOT SHOW THE HEART RHYTHM, JUST THE HEARTBEAT. THE BME REMOVED AND REPLACED THE CNS. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: ON 04/02/2025, NK FIELD SUPPORT ENGINEER (JU) ASSIGNED TWO GZ'S TO THE CNS FOR TESTING, ONE GZ IN SIMULATION MODE AND THE OTHER ATTACHED TO A SIMULATOR. THE REPORTED ISSUE COULD NOT BE DUPLICATED, AND DATA WAS EFFECTIVELY TRANSMITTED WITHOUT ANY FAILURES OR DROPOUTS. TESTING CONTINUED FOR OVER TWO DAYS WITHOUT ANY ISSUES. SINCE THE ISSUE COULD NOT BE DUPLICATED, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. A REVIEW OF THE DEVICE'S SERIAL NUMBER DID NOT YIELD ANY COMPARABLE INCIDENTS. A REVIEW OF COMPLAINTS BY CUSTOMER ACCOUNT DID NOT YIELD ANY SIMILAR EVENTS FOR CNS DEVICES. NK WILL CONTINUE TO MONITOR ANY FUTURE OCCURRENCES. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. D9 DEVICE AVAILABLE FOR EVALUATION? 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.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) KEEPS LOSING THE VITAL SIGNS ON THE PATIENT; THE VITAL SIGNS GOES AWAY THEN THEY COME BACK AND IT DOES NOT SHOW THE HEART RHYTHM, JUST THE HEARTBEAT. BME REMOVED AND REPLACED THE CNS. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE'S STATION (CNS) KEPT LOSING THE PATIENT'S VITAL SIGNS. THE VITAL SIGNS WOULD GO AWAY THEN COME BACK AND WOULD NOT SHOW THE HEART RHYTHM, ONLY THE HEARTBEAT. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1593167 PU-681RA CENTRAL MONITORING SYSTEM MHX NIHON KOHDEN CORPORATION PU-681RA NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown