MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION NIHON KOHDEN LIFE SCOPE G7 BEDSIDE MONITORING SYSTEM

Model Number	CU-172R
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor is not detecting hr with pacing detection enabled.It is false alarming asystole.With pacing detection disabled, they are getting a hr and they asystole alarm stops.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.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor is not detecting hr with pacing detection enabled.It is false alarming asystole.With pacing detection disabled, they are getting a hr and they asystole alarm stops.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor is not detecting hr with pacing detection enabled.It is false alarming asystole.With pacing detection disabled, they are getting a hr and they asystole alarm stops.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor is not detecting hr with pacing detection enabled.It is false alarming asystole.With pacing detection disabled, they are getting a hr and they asystole alarm stops.No patient harm was reported.Investigation conclusion: the customer reported that the unit was not detecting heart rate (hr) with pacing detection enabled and was falsely alarming asystole.With pacing detection disabled, the hr value was obtained, and the asystole alarm stopped.An investigation was completed by nkc (nihon kohden corporation).The cause of the reported issue was determined to be a phenomenon known as pseudofusion beats.Pseudofusion beats may occur when the heart rate matches the pacemaker's rate or when the pr interval matches the pacemaker's av delay.As a countermeasure, changing the electrode position may change the position of the qrs peak and the position where the pacing pulse is detected, potentially preventing missed qrs counts.However, if changing the electrode position does not resolve the issue, this indicates a performance limit.Turning pacing detection off should return the count to normal, but caution is required as asystole and bradycardia may not be detected if pacing insufficiency causes a situation where only pacing pulses are generated and no qrs is generated.Since this case appeared to be av sequential pacing, the cause was likely a match between the av delay setting of the pacemaker device and the patient's own pr interval.It may be worth suggesting changing the av delay on the pacemaker device; however, this may not be possible due to the nature of the treatment.Additional device information: the following field(s) contains no information (ni), as attempts to obtain information were made, but not provided.D10 concomitant medical device.Attempt #1: 03/02/2025 emailed customer via microsoft outlook for all items under the no information section.The customer responded back, but they did not provide the additional device information.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: NIHON KOHDEN LIFE SCOPE G7 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: 24553936
• Report Number: 8030229-2026-06297
• Device Sequence Number: 8859911
• Product Code: MHX
• UDI-Device Identifier: 04931921004517
• UDI-Public: (01)04931921004517
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/07/2026

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-172R
• Device Catalogue Number: CU-172R
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2022
• 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