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

Model Number	BSM-1733
Medical Device Problem Codes	Power Problem (3010); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bsm-1733a randomly shut down during transport.He changed the batteries and after 10 hours, the device got very hot.At the time of the call, the bsm would not power on.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: d10 attempt # 1: 12/23/2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 12/28/2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 3: 01/05/2026 emailed the customer via microsoft outlook for the information in the ni list above: the customer replied, stating that the bsm was connected to an unspecified brand of cns (not nk's).
Event or Problem Description
The biomedical engineer (bme) reported that the bsm-1733a randomly shut down during transport.He changed the batteries and after 10 hours, the device got very hot.At the time of the call, the bsm would not power on.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the bsm-1733a randomly shut down during transport.He changed the batteries and after 10 hours, the device got very hot.At the time of the call, the bsm would not power on.No patient harm was reported.Investigation summary: multiple attempts have been made to request additional information and the return of the reported device for evaluation.However, no response was received and the device was never sent in.Therefore, no further investigation could be performed.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 12/23/2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 12/28/2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 3: 01/05/2026 emailed the customer via microsoft outlook for the information in the ni list above: the customer replied, stating that the bsm was connected to an unspecified brand of cns (not nk's).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 biomedical engineer (bme) reported that the bsm-1733a randomly shut down during transport.He changed the batteries and after 10 hours, the device got very hot.At the time of the call, the bsm would not power on.No patient harm was reported.

• 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: 24026121
• Report Number: 8030229-2026-06043
• Device Sequence Number: 9191690
• Product Code: MHX
• UDI-Device Identifier: 04931921111833
• UDI-Public: (01)04931921111833
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: BSM-1733
• Device Catalogue Number: BSM-1733A
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2022
• 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