MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION LIFE SCOPE G9; BEDSIDE MONITOR

Model Number	CU-192R
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The charge nurse reported that the g9 monitor did not alarm for spo2.The spo2 dropped to 44 when the alarm limit was set at 89, which should have triggered an alarm.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.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 08/19/2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 08/20/2025 emailed the customer via microsoft outlook for the information in the ni list above: the customer replied but was confused about the information that was requested.Ultimately, the information could not be obtained or was not available to the contact.
Event or Problem Description
The charge nurse reported that the g9 monitor did not alarm for spo2.The spo2 dropped to 44 when the alarm limit was set at 89, which should have triggered an alarm.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the charge nurse reported that the g9 monitor did not alarm for spo2.The spo2 dropped to 44 when the alarm limit was set at 89, which should have triggered an alarm.No patient harm was reported.Investigation summary: nk's cas checked the available review data and could not confirm the issue.The review data from the occurrence date was no longer available and the customer stated that the ticket could be closed.The complaint device was not returned to nk for evaluation.As such, a root cause could not be determined.Nk will continue to monitor and trend.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 08/19/2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 08/20/2025 emailed the customer via microsoft outlook for the information in the ni list above: the customer replied but was confused about the information that was requested.Ultimately, the information could not be obtained or was not available to the customer.Additional information: b4 date of this report.E3 occupation.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type?.H3 device evaluated by manufacturer?.H6 event problem and evaluation codes.H11 additional manufacturer narrative.
Event or Problem Description
The charge nurse reported that the g9 monitor did not alarm for spo2.The spo2 dropped to 44 when the alarm limit was set at 89, which should have triggered an alarm.No patient harm was reported.

• Brand Name: LIFE SCOPE G9
• 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: 23028414
• Report Number: 8030229-2025-05478
• Device Sequence Number: 18498768
• Product Code: MHX
• UDI-Device Identifier: 04931921112168
• UDI-Public: (01)04931921112168
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K213316
• 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): 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-192R
• Device Catalogue Number: CU-192RA
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2021
• 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