MAUDE Adverse Event Report: Nihon Kohden Corporation Life Scope PT; Bedside Monitor

Model Number	BSM-1753
Medical Device Problem Codes	Computer Software Problem (1112); Application Program Problem (2880); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the anesthesiologist encountered an error message on a g5 transport monitor during a surgical procedure.During the procedure, the monitor displayed the following error message: input unit error - the input unit software version is incompatible with the main unit.The data in the input unit will be deleted." because the operating room is currently in patient use, we were unable to verify the serial number or software version of the main unit.The affected bsm-1753a transport monitor is running software version 02-67.Tech support (ts) advised the bme that they would like to compare the software version of the spare transport monitor that was successfully used in its place to determine whether a software version mismatch may have caused the error.The bme stated he will call back with the software version of the spare transport monitor so we can continue troubleshooting which they have not done they did call back with the initial bsm-1753a transport monitor with the error message and took it to another room and docked it to another bsm-6701a bedside monitor (bsm).The bsm-6701a went into a boot loop sequence.It would show connect input unit even though the transport monitor was docked on the back side and then flash a bunch of codes with an error message of ***data abort / wp error***.Tech support consulted with the repair center about the error message, and it was suggested that the mainboard be replaced on the bsm-6701a ur-39451 main digital board, mu-671.The bme is thinking the issue is more so with the transport unit since they have experienced two different issues with the same transport monitor.The bme is going to do additional troubleshooting and call back with his findings.Qa asked the customer the following questions, but the bme has been unresponsive.What was the model and serial number and software version of the main unit that the transport unit plugs into? what was the software version of the spare transport unit that replaced the affected unit? what happened when you connected another transport unit to the bsm-6701a that went into a boot loop sequence? no patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the anesthesiologist encountered an error message on a g5 transport monitor during a surgical procedure.During the procedure, the monitor displayed the following error message: input unit error - the input unit software version is incompatible with the main unit.The data in the input unit will be deleted." because the operating room is currently in patient use, we were unable to verify the serial number or software version of the main unit.The affected bsm-1753a transport monitor is running software version 02-67.Tech support (ts) advised the bme that they would like to compare the software version of the spare transport monitor that was successfully used in its place to determine whether a software version mismatch may have caused the error.The bme stated he will call back with the software version of the spare transport monitor so we can continue troubleshooting which they have not done they did call back with the initial bsm-1753a transport monitor with the error message and took it to another room and docked it to another bsm-6701a bedside monitor (bsm).The bsm-6701a went into a boot loop sequence.It would show connect input unit even though the transport monitor was docked on the back side and then flash a bunch of codes with an error message of ***data abort / wp error***.Tech support consulted with the repair center about the error message, and it was suggested that the mainboard be replaced on the bsm-6701a ur-39451 main digital board, mu-671.The bme is thinking the issue is more so with the transport unit since they have experienced two different issues with the same transport monitor.The bme is going to do additional troubleshooting and call back with his findings.Qa asked the customer the following questions, but the bme has been unresponsive.What was the model and serial number and software version of the main unit that the transport unit plugs into? what was the software version of the spare transport unit that replaced the affected unit? what happened when you connected another transport unit to the bsm-6701a that went into a boot loop sequence? 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.

• Brand Name: Life Scope PT
• Common Device Name: Bedside Monitor
• Manufacturer (Section D): Nihon Kohden Corporation; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): Nihon Kohden Corporation; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 50452921
• Report Number: 8030229-2026-06972
• Device Sequence Number: 10281619
• Product Code: MHX
• UDI-Device Identifier: 04931921111871
• UDI-Public: (01)04931921111871
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BSM-1753
• Device Catalogue Number: BSM-1753A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown