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

Model Number	BSM-3532
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that this bedside monitor (bsm) was not providing the ecg or spo2 readings until they rebooted the unit.The unit was not in patient use at the time.
Additional Manufacturer Narrative
The customer reported that this bedside monitor (bsm) was not providing the ecg or spo2 readings until they rebooted the unit.After rebooting, the unit displayed a flatline for the ecg and spo2 when testing with a simulator.The issue was discovered during setup.The customer changed the leads and the spo2 probe; however, they still didn't see a rhythm.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.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10.Attempt # 1: (b)(6) 2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: (b)(6) 2026 i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.Attempt # 3: (b)(6) 2026 i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for rose to call me back with this information.The following fields are not available (n/a) to this report: h4 device manufacturer date.
Event or Problem Description
The customer reported that this bedside monitor (bsm) was not providing the ecg or spo2 readings until they rebooted the unit.The unit was not in patient use at the time.
Additional Manufacturer Narrative
Details of complaint: the customer reported that this bedside monitor (bsm) was not providing the ecg or spo2 readings until they rebooted the unit.After rebooting, the unit displayed a flatline for the ecg and spo2 when testing with a simulator.The issue was discovered during setup.The customer changed the leads and the spo2 probe; however, they still didn't see a rhythm.The unit was not in patient use at the time.Investigation summary: the device with the reported issue was returned for evaluation.During the evaluation, the reported issue could not be duplicated; therefore, the complaint could not be confirmed.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow up, what type? h3 device evaluated by manufacturer? h4 device manufacturer date h11 additional manufacturer narrative.

• Brand Name: LIFE SCOPE VS
• 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: 24603947
• Report Number: 8030229-2026-06285
• Device Sequence Number: 9229553
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: (01)04931921113660
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K201949
• 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): 04/07/2026

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-3532
• Device Catalogue Number: BSM-3532A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2022
• 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