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

Model Number	MU-631RA
Medical Device Problem Codes	Delayed Alarm (1011); Device Alarm System (1012); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the alarms are not sounding when expected, and the screen has a banner reading: "alarm suspended." this happens after suspending an alarm.It takes 30 seconds longer than the set time to resume monitoring and alarming.They also felt that if a patient's heart rate reached 190, it should not just alarm for warning.Tech support stated that it is possible with extended arrhythmia settings to alarm differently.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.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 (b)(6) 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 as requested.
Event or Problem Description
The customer reported that the alarms are not sounding when expected, and the screen has a banner reading: "alarm suspended." this happens after suspending an alarm.It takes 30 seconds longer than the set time to resume monitoring and alarming.They also felt that if a patient's heart rate reached 190, it should not just alarm for warning.Tech support stated that it is possible with extended arrhythmia settings to alarm differently.No patient harm was reported.
Additional Manufacturer Narrative
The customer reported that the alarms are not sounding when expected, and the screen has a banner reading: "alarm suspended." this happens after suspending an alarm.It takes 30 seconds longer than the set time to resume monitoring and alarming.They also felt that if a patient's heart rate reached 190, it should not just alarm for warning.Tech support stated that it is possible with extended arrhythmia settings to alarm differently.No patient harm was reported.Investigation conclusion: review of the complaint device's serial number found that the software version was over 10 years old.Further troubleshooting was not available.The complaint device would not be returned to nk.The complaint could not be confirmed.Root cause could not be determined.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 09/09/2025 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 as requested.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.
Event or Problem Description
The customer reported that the alarms are not sounding when expected, and the screen has a banner reading: "alarm suspended." this happens after suspending an alarm.It takes 30 seconds longer than the set time to resume monitoring and alarming.They also felt that if a patient's heart rate reached 190, it should not just alarm for warning.Tech support stated that it is possible with extended arrhythmia settings to alarm differently.No patient harm was reported.

• Brand Name: LIFE SCOPE TR
• 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: 23022798
• Report Number: 8030229-2025-05467
• Device Sequence Number: 9455164
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: (01)04931921103517
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K080342
• 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): 11/21/2025

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: MU-631RA
• Device Catalogue Number: MU-631RA
• 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: 09/08/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2010
• 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