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

Model Number	MU-631RA
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Output Problem (3005); No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) went blank while they were working on a patient in er.There was an rts error message on their bsm-6301a during boot-up, along with touchscreen issues where only half of the monitor was working.The bsm-6301a would not boot up normally.Upon startup, the screen goes blank, displays a fault error, and all values default to zero.The transport module - the bsm-1700 connected to the bsm-6301a was removed and docked to another bedside monitor to continue monitoring the patient.The customer does not know what bsm-1700 model was being used with the bsm-6301a.No patient harm reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor (bsm) went blank while they were working on a patient in er.There was an rts error message on their bsm-6301a during boot-up, along with touchscreen issues where only half of the monitor was working.The bsm-6301a would not boot up normally.Upon startup, the screen goes blank, displays a fault error, and all values default to zero.The transport module - the bsm-1700 connected to the bsm-6301a was removed and docked to another bedside monitor to continue monitoring the patient.The customer does not know what bsm-1700 model was being used with the bsm-6301a.No patient harm 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(s) contains no information (ni), as attempts to obtain information were made, but not provided.D10 concomitant medical device.Attempt #1 on (b)(6) 2025 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the additional device information as requested.Bedside monitor bsm-1700 series, model: ni, sn: ni, device manufacturer date: ni, unique identifier (udi) #: ni, returned to nihon kohden: not returned.
Additional Manufacturer Narrative
Details of the complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) went blank while they were working on a patient in er.There was an rts error message on their bsm-6301a during boot-up, along with touchscreen issues where only half of the monitor was working.The bsm-6301a would not boot up normally.Upon startup, the screen goes blank, displays a fault error, and all values default to zero.The transport module - the bsm-1700 connected to the bsm-6301a was removed and docked to another bedside monitor to continue monitoring the patient.The customer does not know what bsm-1700 model was being used with the bsm-6301a.No patient harm reported.Investigation conclusion: the complaint device was received.The unit was evaluated and the complaint was duplicated.The cause was circuit board failure, likely due to physical damage from user mishandling and wear-and-tear as the device was installed over 13 years ago.The following field(s) contains no information (ni), as attempts to obtain information were made, but not provided.D10 concomitant medical device.Attempt #1 04/28/2025 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the additional device information as requested.Bedside monitor bsm-1700 series.Model: ni.Sn: ni.Device manufacturer date: 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) went blank while they were working on a patient in er.There was an rts error message on their bsm-6301a during boot-up, along with touchscreen issues where only half of the monitor was working.The bsm-6301a would not boot up normally.Upon startup, the screen goes blank, displays a fault error, and all values default to zero.The transport module - the bsm-1700 connected to the bsm-6301a was removed and docked to another bedside monitor to continue monitoring the patient.The customer does not know what bsm-1700 model was being used with the bsm-6301a.No patient harm 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: 21931407
• Report Number: 8030229-2025-04929
• Device Sequence Number: 15616071
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: (01)04931921103517
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 07/29/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2011
• 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; BEDSIDE MONITOR
• Patient Sex: Unknown