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

Model Number	CU-152R
Medical Device Problem Codes	No Audible Alarm (1019); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that this unit missed crisis alarms.There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported that this unit missed crisis alarms.The customer checked the alarm limits and confirmed that they were set correctly.According to the customer, values under 80 should have triggered a crisis alarm.The customer will pull the logs and wants nihon kohden (nk) to review them.The customer wants to know why the alarm didn't activate when the value dropped below the set limit.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
Details of complaint: the customer reported that this unit missed crisis alarms.The customer checked the alarm limits and confirmed that they were set correctly.According to the customer, values under 80 should have triggered a crisis alarm.The customer will pull the logs and wants nihon kohden (nk) to review them.The customer wants to know why the alarm didn't activate when the value dropped below the set limit.There was no patient injury reported.Investigation summary: the device was not available for evaluation and the customer did not provide any logs for review; therefore, a root cause could not be determined.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 09/23/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 09/25/2025 i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.Attempt # 3: 09/29/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type?.H11 additional manufacturer narrative.
Event or Problem Description
The customer reported that this unit missed crisis alarms.There was no patient injury reported.

• 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: 23192706
• Report Number: 8030229-2025-05450
• Device Sequence Number: 9182793
• Product Code: MHX
• UDI-Device Identifier: 04931921002056
• UDI-Public: (01)04931921002056
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 09/02/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2024
• 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