BEUDAMED
    FDA Adverse Event Death Summary report: N

    PU-681RA

    MDR report key: 22415044 · Received July 7, 2025

    Report

    Report Number
    8030229-2025-05157
    Event Type
    Death
    Date Received
    July 7, 2025
    Date of Event
    June 10, 2025
    Report Date
    September 5, 2025
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE HOSPITAL'S RISK MANAGER AT THE HOSPITAL REPORTED THAT AFTER RETURNING FROM A PROCEDURE, THE PATIENT EXPIRED WHILE BEING MONITORED AT THE CENTRAL NURSE'S STATION (CNS). THIS OCCURRED ON (B)(6) 2025 AT 1200 HOURS. THE LOGS ARE CURRENTLY BEING PULLED FROM THE DEVICES. SHE WAS CONCERNED BECAUSE IN THE PAST, MONITOR TECHS HAD BEEN SILENCING THE ALARMS, AND THEY WANT TO VERIFY THAT THIS IS NOT THE CASE WITH THIS EVENT. SHE ALSO WANTED TO SEE WHAT HAPPENED WITH THE PATIENT. INVESTIGATION SUMMARY: THE LOG FILES FROM THE REPORTED DEVICE WERE SENT IN FOR REVIEW. REVIEW OF THE CNS LOGS SHOWED THAT THE DEVICE GENERATED ALARMS, WITH SOME INSTANCES OF USER OPERATION MANUALLY SILENCING THE ALARMS NEAR THE REPORTED OCCURRENCE TIME. THE CUSTOMER STATED REVIEW DATA PRINTOUTS FOR THE PATIENT WERE NOT AVAILABLE, SO IT COULD NOT BE COMPLETELY CONFIRMED IF THE CNS GENERATED ALARMS APPROPRIATELY. THE ROOT CAUSE COULD NOT BE DETERMINED BUT THE ISSUE MAY HAVE BEEN ATTRIBUTED TO USER ERROR. NK WILL CONTINUE TO MONITOR AND TREND. THE FOLLOWING FIELD CONTAINS LIMITED INFORMATION, AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10 ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS: MULTIPLE PATIENT RECEIVER (ORG): MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTER: MODEL #: ZM-531PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 09/25/2020. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA. ADDITIONAL INFORMATION: B1 REPORT TYPE. 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 HOSPITAL'S RISK MANAGER AT THE HOSPITAL REPORTED THAT AFTER RETURNING FROM A PROCEDURE, THE PATIENT EXPIRED WHILE BEING MONITORED AT THE CENTRAL NURSE'S STATION (CNS). THIS OCCURRED ON (B)(6) 2025 AT 1200 HOURS. THE LOGS ARE CURRENTLY BEING PULLED FROM THE DEVICES. SHE WAS CONCERNED BECAUSE IN THE PAST, MONITOR TECHS HAD BEEN SILENCING THE ALARMS, AND THEY WANT TO VERIFY THAT THIS IS NOT THE CASE WITH THIS EVENT. SHE ALSO WANTED TO SEE WHAT HAPPENED WITH THE PATIENT. 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. THE FOLLOWING FIELD CONTAINS LIMITED INFORMATION, AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10 ATTEMPT # 1: 06/12/2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 06/25/2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 07/07/2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE CNS: MULTIPLE PATIENT RECEIVER (ORG): MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTER: MODEL #: ZM-531PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 09/25/2020. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA.

    Description of Event or Problem · 0

    THE HOSPITAL'S RISK MANAGER AT THE HOSPITAL REPORTED THAT AFTER RETURNING FROM A PROCEDURE, THE PATIENT EXPIRED WHILE BEING MONITORED AT THE CENTRAL NURSE'S STATION (CNS). THIS OCCURRED ON (B)(6) 2025 AT 1200 HOURS.

    Description of Event or Problem · 0

    THE HOSPITAL'S RISK MANAGER AT THE HOSPITAL REPORTED THAT AFTER RETURNING FROM A PROCEDURE, THE PATIENT EXPIRED WHILE BEING MONITORED AT THE CENTRAL NURSE'S STATION (CNS). THIS OCCURRED ON (B)(6) 2025 AT 1200 HOURS. THE LOGS ARE CURRENTLY BEING PULLED FROM THE DEVICES. SHE WAS CONCERNED BECAUSE IN THE PAST, MONITOR TECHS HAD BEEN SILENCING THE ALARMS, AND THEY WANT TO VERIFY THAT THIS IS NOT THE CASE WITH THIS EVENT. SHE ALSO WANTED TO SEE WHAT HAPPENED WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038507 PU-681RA CENTRAL MONITORING SYSTEM MHX NIHON KOHDEN CORPORATION PU-681RA NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death MULTIPLE PATIENT RECEIVER (ORG)| MULTIPLE PATIENT RECEIVER (ORG)| ZM TRANSMITTER| ZM TRANSMITTER