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

Model Number	BSM-1753
Medical Device Problem Codes	No Display/Image (1183); Output Problem (3005); Power Problem (3010); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that this bedside monitor (bsm) is not staying on while under battery power.The customer mentioned that the 1700 was also not taking nibp readings before the issue with the power started.The unit was not in patient use at the time.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 customer reported that this bedside monitor (bsm) is not staying on while under battery power.The unit was not in patient use at the time.
Additional Manufacturer Narrative
Details of complaint: the customer reported that this bedside monitor (bsm) is not staying on while under battery power.The customer mentioned that the 1700 was also not taking nibp readings before the issue with the power started.The unit was not in patient use at the time.Investigation summary: the device was returned for evaluation.During testing of the unit, the reported issues could not be duplicated.The unit powered on and the battery charge lasted approximately five hours.The unit appropriately charged the battery when connected to a host monitor.The nibp vitals were simulated at 120/80 and 190/120 using a simulator and the measurements were withing tolerable range for the simulated values.The unit passed all other functional tests.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 10/03/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 10/08/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: 10/13/2025 emailed the customer via microsoft outlook for all information in the ni list above: the customer replied that none of the requested information can be provided.Additional information: b4 date of this report.D9 is this device available for evaluation?.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type?.H3 device evaluated by manufacturer?.H11 additional manufacturer narrative.
Event or Problem Description
The customer reported that this bedside monitor (bsm) is not staying on while under battery power.The unit was not in patient use at the time.

• Brand Name: LIFE SCOPE PT
• 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 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: 23290125
• Report Number: 8030229-2025-05537
• Device Sequence Number: 14675001
• Product Code: MHX
• UDI-Device Identifier: 04931921111871
• UDI-Public: (01)04931921111871
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K220976
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: BSM-1753
• Device Catalogue Number: BSM-1753A
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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