BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PU-681RA

    MDR report key: 22366317 · Received June 30, 2025

    Report

    Report Number
    8030229-2025-05012
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 2, 2025
    Report Date
    September 16, 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
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THIS CENTRAL NURSE'S STATION (CNS) DISPLAYED A B4 ERROR CODE MESSAGE. ACCORDING TO THE CUSTOMER, THE UNIT WILL NOT BOOT WITH THE ALARM INDICATOR PLUGGED IN. THIS ISSUE WAS FIRST REPORTED UNDER TICKET (B)(4) AND THE ISSUE WAS BELIEVED TO BE RESOLVED. PER THE CUSTOMER, IN ORDER TO GET THE UNIT TO BOOT UP, THEY NEED TO UNPLUG THE ALARM INDICATOR, LET IT BOOT THEN PLUG IT BACK IN FOR NORMAL OPERATION. THE CUSTOMER STATED THAT THIS IS NOT ACCEPTABLE AS THERE'S SOME KIND OF POWER FAILURE OR UNSCHEDULED REBOOT WHEN BIOMED IS NOT THERE. THE CUSTOMER WANTS THE UNIT EVALUATED. THERE WAS NO PATIENT INJURY 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 CUSTOMER REPORTED THAT THIS CENTRAL NURSE'S STATION (CNS) DISPLAYED A B4 ERROR CODE MESSAGE. ACCORDING TO THE CUSTOMER, THE UNIT WILL NOT BOOT WITH THE ALARM INDICATOR PLUGGED IN. THIS ISSUE WAS FIRST REPORTED UNDER TICKET 234063 AND THE ISSUE WAS BELIEVED TO BE RESOLVED. PER THE CUSTOMER, IN ORDER TO GET THE UNIT TO BOOT UP, THEY NEED TO UNPLUG THE ALARM INDICATOR, LET IT BOOT THEN PLUG IT BACK IN FOR NORMAL OPERATION. THE CUSTOMER STATED THAT THIS IS NOT ACCEPTABLE AS THERE'S SOME KIND OF POWER FAILURE OR UNSCHEDULED REBOOT WHEN BIOMED IS NOT THERE. THE CUSTOMER WANTS THE UNIT EVALUATED. THERE WAS NO PATIENT INJURY REPORTED. INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED AND EVALUATED. DURING THE EVALUATION OF THE DEVICE, THE UNIT WAS REBOOTED SEVERAL TIMES WITH PROPER ALARM INDICATOR CONNECTED AND THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE FOLLOWING FIELD(S) CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10 ATTEMPT # 1: 06/19/2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 06/23/2025 I CALLED (B)(6) TO GET MODEL AND SERIAL NUMBERS OF ANY DEVICE(S) THE REPORTED DEVICE WAS CONNECTED OR RELATED TO. A MESSAGE WAS LEFT FOR (B)(6) TO CALL ME BACK WITH THIS INFORMATION. ATTEMPT # 3: 06/25/2025 I CALLED (B)(6) TO GET MODEL AND SERIAL NUMBERS OF ANY DEVICE(S) THE REPORTED DEVICE WAS CONNECTED OR RELATED TO. A MESSAGE WAS LEFT FOR (B)(6) TO CALL ME BACK WITH THIS INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THIS CENTRAL NURSE'S STATION (CNS) DISPLAYED A B4 ERROR CODE MESSAGE. THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THIS CENTRAL NURSE'S STATION (CNS) DISPLAYED A B4 ERROR CODE MESSAGE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130426 PU-681RA CENTRAL MONITORING SYSTEM MHX NIHON KOHDEN CORPORATION PU-681RA NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown