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

Model Number	MU-671RA
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor (bsm) non-invasive blood pressure (nibp) pump would intermittently work.They tried multiple known-working bsm-1700 input units, but the issue persisted.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: additional device information: d10 concomitant medical device: the following device was used in conjunction with the bsm: bsm model #: bsm-17xx, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni, returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) non-invasive blood pressure (nibp) pump would intermittently work.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) non-invasive blood pressure (nibp) pump would intermittently work.They tried multiple known-working bsm-(b)(4) input units, but the issue persisted.No patient harm was reported.Investigation summary: the complaint device was received.The unit was evaluated and the complaint could not be duplicated.The 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: 12/05/2025 emailed the bme for all information in the ni list above: no reply was received.Attempt # 2: 12/09/2025 emailed the bme for all information in the ni list above: the bme replied, but did not provide the requested information.Attempt # 3: 12/18/2025 emailed the bme for all 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 bsm: bsm.Model #: bsm-17xx.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: not returned.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 biomedical engineer (bme) reported that the bedside monitor (bsm) non-invasive blood pressure (nibp) pump would intermittently work.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: 23850677
• Report Number: 8030229-2025-05911
• Device Sequence Number: 15838666
• Product Code: MHX
• UDI-Device Identifier: 04931921103562
• UDI-Public: (01)04931921103562
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/26/2026

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-671RA
• Device Catalogue Number: MU-671RA
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2020
• 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: BSM; BSM
• Patient Sex: Unknown