MAUDE Adverse Event Report: Nihon Kohden Corporation Life Scope G9; Bedside Monitor

Model Number	CU-192R
Medical Device Problem Codes	Display Difficult to Read (1181); Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/04/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The biomedical engineer (biomed) reported that on (b)(6) 2026 at approximately 7:30am, the g9 monitor displayed a "host monitor software too old" error message.He stated that due to the error message, the vitals were not displayed on the g9 monitor and the patient expired.The vitals appeared on the bsm-1700, but when it was docked to the g9, they did not display.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 fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2-a6, b6, b7.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the g9 monitor: bedside monitor (bsm): model#: bsm-1753a, serial#: (b)(6), device manufacturer data: 01/30/2014, unique identifier (udi) #: (b)(4), returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (biomed) reported that on (b)(6) 2026 at approximately 7:30am the g9 monitor displayed a "host monitor software too old" error message.He stated that due to the error message, the vitals were not displayed on the g9 monitor and the patient expired.The vitals appeared on the bsm-1700, but when it was docked to the g9, they did not display.
Event or Problem Description
The biomedical engineer (biomed) reported that on 06/04/2026 at approximately 7:30am the g9 monitor displayed a "host monitor software too old" error message.He stated that due to the error message, the vitals were not displayed on the g9 monitor and the patient expired.The vitals appeared on the bsm-1700, but when it was docked to the g9, they did not display.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (biomed) reported that on (b)(6)2026 at approximately 7:30am the g9 monitor displayed a "host monitor software too old" error message.He stated that due to the error message, the vitals were not displayed on the g9 monitor and the patient expired.The vitals appeared on the bsm-1700, but when it was docked to the g9, they did not display.Investigation summary: the log files were sent in for review, and the root cause of the reported condition was identified to be software incompatibility.The concomitant bsm-1700 series bedside monitor was software version 01-06, and software version 01-08 or later is required to utilize a csm-1901 host monitor.When the host monitor software does not support use with the bsm-1700 series bedside monitor, there is an "unsupported host monitor version" alarm, and the bsm-1700 series bedside monitor cannot be used as an input unit.Nihon kohden will continue to trend and monitor.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2-a6 b6 b7 attempt # 1: (b)(6)2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: (b)(6)2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 3: (b)(6)2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the g9 monitor: bedside monitor (bsm): model #: bsm-1753a.Serial #: (b)(6).Device manufacturer data: 01/30/2014.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H11 additional manufacturer narrative.

• 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: 25638186
• Report Number: 8030229-2026-06768
• Device Sequence Number: 9836963
• Product Code: MHX
• UDI-Device Identifier: 04931921112168
• UDI-Public: (01)04931921112168
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2020
• 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: Bedside Monitor (BSM-1753A).
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown