MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION NIHON KOHDEN LIFE SCOPE G5 BEDSIDE MONITORING SYSTEM; VITAL SIGNS MONITOR

Model Number	CU-151R
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that this unit has had a vertical static bar like interference.The customer corrected the issue by shutting down the unit and unplugging the bedside monitor.According to the customer, they have never seen this issue until software 2-28 was installed.The technical service account manager will be uploading the logs.The unit was not in patient use at the time.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.
Event or Problem Description
The customer reported that this unit has had a vertical static bar like interference.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that this unit has had a vertical static bar like interference.The customer corrected the issue by shutting down the unit and unplugging the bedside monitor.According to the customer, they have never seen this issue until software 2-28 was installed.The technical service account manager will be uploading the logs.The unit was not in patient use at the time.Investigation summary: nihon kohden confirmed the issue was attributed to a software issue that occurred after upgrading the system from software version 02.27 to software version 02.28.The root cause was determined to be a software malfunction of the commercial rtos (kernel) used in the g5/g7 software (version 02.28).Kernel is a part of core software that manages and controls the operating system and a software malfunction occurred with kernel, leading to the reported issue.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 04/05/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have access to patient information.B6 attempt # 1: 04/05/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have access to patient information.B7 attempt # 1: 04/05/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have access to patient information.D10 attempt # 1: 04/05/2024 emailed the customer via microsoft outlook for device information: the customer replied by stating; i don't have access to patient information.Additional information: b4 date of this report.D9 is the device available for evaluation? g3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h3 device evaluated by manufacturer? h11 additional manufacturer narrative.Manufacturer references # (b)(4( follow up 001.
Event or Problem Description
The customer reported that this unit has had a vertical static bar like interference.There was no patient injury reported.
Additional Manufacturer Narrative
**udi related data quality updates** corrected information: d1 brand name: corrected the brand name from csm-1501 to nihon kohden life scope g5 bedside monitoring system.D4 additional device information / model #: corrected the model # from csm-1501 to cu-151r.D4 additional device information / catalog #: corrected the catalog # from csm-1501 to cu-151r.D4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the pi information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.
Event or Problem Description
The customer reported that this unit has had a vertical static bar like interference.There was no patient injury reported.

• Brand Name: NIHON KOHDEN LIFE SCOPE G5 BEDSIDE MONITORING SYSTEM
• Common Device Name: VITAL SIGNS 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: 19134667
• Report Number: 8030229-2024-04223
• Device Sequence Number: 4658208
• Product Code: MHX
• UDI-Device Identifier: 04931921002018
• UDI-Public: (01)04931921002018(21)104
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2025

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-151R
• Device Catalogue Number: CU-151R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 07/17/2024; 07/17/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 07/18/2024; 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.; NI.; NI.
• Patient Sex: Unknown