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

Model Number	CU-151R
Medical Device Problem Codes	Unable to Obtain Readings (1516); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Details of complaint: the customer reported that the gas analyzer was not taking readings while on a case.According to the customer, all connections appeared to be secure.Technical support (ts) had the customer reboot the unit by removing the power.Once the unit came back up, they were able to see etco2 and the respiratory rate (rr).There was no patient injury reported.Investigation summary: the issue was resolved by rebooting the gas analyzer.A definitive root cause could not be determined from the resolution details.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: (b)(6) 2024 a phone call was made in an attempt to gather device information; a message was left for (b)(6) to call me back with this information.Attempt # 2: (b)(6) 2024 a phone call was made in an attempt to gather device information; a message was left for (b)(6) to call me back with this information.Attempt # 3: (b)(6) 2024 a phone call was made in an attempt to gather device information; a message was left for (b)(6) to call me back with this information.The following fileds are not available (n/a) to this report: h4 device manufacturer date: 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 the gas analyzer was not taking readings while on a case.There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported that the gas analyzer was not taking readings while on a case.According to the customer, all connections appeared to be secure.Technical support (ts) had the customer reboot the unit by removing the power.Once the unit came back up, they were able to see etco2 and the respiratory rate (rr).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.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: d10 the following fileds are not available (n/a) to this report: h4 device manufacturer date.
Event or Problem Description
The customer reported that the gas analyzer was not taking readings while on a case.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: 21020594
• Report Number: 8030229-2024-04612
• Device Sequence Number: 18436834
• Product Code: MHX
• UDI-Device Identifier: 04931921002018
• UDI-Public: (01)04931921002018
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 03/18/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.
• Patient Sex: Unknown