MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION NIHON KOHDEN LIFE SCOPE G5 BEDSIDE MONITORING SYSTEM

Model Number	CU-152R
Medical Device Problem Codes	Application Program Problem: Parameter Calculation Error (1449); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The nurse reported that the g5 monitor was receiving "analyzing data" on 12-lead and no 12-lead analysis were given.The waveforms were displayed, but intermittently.No patient harm was reported.
Additional Manufacturer Narrative
The nurse reported that the g5 monitor was receiving "analyzing data" on 12-lead and no 12-lead analysis were given.The waveforms were displayed, but intermittently.Technical support (ts) had them reboot the g5, but the issue persisted and they did not have another trunk cable immediately available.The biomedical engineer (bme) called back after attempting to troubleshoot the issue.After rebooting, it displayed a disc error, prompting them to initialize the device.However, after initializing, another error stating "cannot save data" was displayed.The bme noted that while trying to induce alarms, the settings were not saving when being adjusted.Ts advised to replace the internal sd card and provided them with the part number.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: d10 concomitant medical device: the following device was used in conjunction with the g5 monitor: bedside monitor (bsm): model #: bsm-1753a serial #: ni device manufacturer data: ni unique identifier (udi) #: (b)(4) returned to nihon kohden: na.

• Brand Name: NIHON KOHDEN LIFE SCOPE G5 BEDSIDE MONITORING SYSTEM
• 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 TOMIOKA 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: 24648131
• Report Number: 8030229-2026-06289
• Device Sequence Number: 13279368
• Product Code: MHX
• UDI-Device Identifier: 04931921002056
• UDI-Public: (01)04931921002056
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K203435
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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: CU-152R
• Device Catalogue Number: CU-152R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BSM
• Patient Sex: Unknown