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

Model Number	MU-631RA
Medical Device Problem Codes	No Audible Alarm (1019); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the staff is claiming the unit did not alarm when the patient had an elevated heartrate.The patient was discharged from the ed and admitted to another department where they coded upon admit.Staff looked into the emr for the patient and saw the elevated hr of over 150bpm but were unable to verify if the alarms went off at the central nurse's station (cns) in the review data due to the patient being discharged.When tech support (ts) asked the customer if they saw an alarm in the emr for the elevated hr, they stated that their emr doesn't record if there is an alarm or not and only records the values ts informed the customer that unfortunately, because this happened so long ago, the data will be missing from the cns.The customer was unaware that we could see if a unit alarmed via logs if it was within a few days.Due to the nature of the issue at hand and that it was reported that a patient coded after transfer, ts is initiating an adverse event investigation, even though the customer refuses to confirm if there was harm/death or not.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: d10 concomitant medical device.Central nurse's station.Model: pu-681ra.Sn: (b)(6).
Event or Problem Description
The customer reported that the staff is claiming the unit did not alarm when the patient had an elevated heartrate.The patient was discharged from the ed and admitted to another department where they coded upon admit.Staff looked into the emr for the patient and saw the elevated hr of over 150bpm but were unable to verify if the alarms went off at the central nurse's station (cns) in the review data due to the patient being discharged.When tech support (ts) asked the customer if they saw an alarm in the emr for the elevated hr, they stated that their emr doesn't record if there is an alarm or not and only records the values ts informed the customer that unfortunately, because this happened so long ago, the data will be missing from the cns.The customer was unaware that we could see if a unit alarmed via logs if it was within a few days.Due to the nature of the issue at hand and that it was reported that a patient coded after transfer, ts is initiating an adverse event investigation, even though the customer refuses to confirm if there was harm/death or not.
Additional Manufacturer Narrative
The customer reported that the staff is claiming the unit did not alarm when the patient had an elevated heartrate.The patient was discharged from the ed and admitted to another department where they coded upon admit.Staff looked into the emr for the patient and saw the elevated hr of over 150bpm but were unable to verify if the alarms went off at the central nurse's station (cns) in the review data due to the patient being discharged.When tech support (ts) asked the customer if they saw an alarm in the emr for the elevated hr, they stated that their emr doesn't record if there is an alarm or not and only records the values.Ts informed the customer that unfortunately, because this happened so long ago, the data will be missing from the cns.The customer was unaware that we could see if a unit alarmed via logs if it was within a few days.Due to the nature of the issue at hand and that it was reported that a patient coded after transfer, ts is initiating an adverse event investigation, even though the customer refuses to confirm if there was harm/death or not.Investigation conclusion: the cns logs were received, but data from the occurrence date 11/24/2025 was not available.The alarm logs only go back to 12/4/2025.The complaint could not be confirmed from the logs.The bedside monitor was received.The unit was evaluated and the complaint could not be duplicated.The device was repaired for having a dim display during testing.Root cause could not be determined.Additional device information: d10 concomitant medical device.Central nurse's station.Model: pu-681ra.Sn: (b)(6).Additional information: b4 date of this report.D9 device available for evaluation.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 customer reported that the staff is claiming the unit did not alarm when the patient had an elevated heartrate.The patient was discharged from the ed and admitted to another department where they coded upon admit.Staff looked into the emr for the patient and saw the elevated hr of over 150bpm but were unable to verify if the alarms went off at the central nurse's station (cns) in the review data due to the patient being discharged.When tech support (ts) asked the customer if they saw an alarm in the emr for the elevated hr, they stated that their emr doesn't record if there is an alarm or not and only records the values ts informed the customer that unfortunately, because this happened so long ago, the data will be missing from the cns.The customer was unaware that we could see if a unit alarmed via logs if it was within a few days.Due to the nature of the issue at hand and that it was reported that a patient coded after transfer, ts is initiating an adverse event investigation, even though the customer refuses to confirm if there was harm/death or not.

• 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: 24016186
• Report Number: 8030229-2026-06009
• Device Sequence Number: 10591203
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: (01)04931921103517
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: MU-631RA
• Device Catalogue Number: MU-631RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2010
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PU-681RA SN (B)(6)
• Patient Sex: Unknown