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

Model Number	BSM-3552
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the bedside monitor was not producing accurate spo2 pulse rate readings as compared to the ecg heart rate readings.They do not have a simulator to test the unit.There was no patient harm reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the bedside monitor was not producing accurate spo2 pulse rate readings as compared to the ecg heart rate readings.They do not have a simulator to test the unit.There was no patient harm reported.Investigation summary: the reported device was returned for evaluation.A physical inspection confirmed the model, serial number, and labels.There were no signs of physical damage or fluid exposure.During testing, the reported issue was duplicated.Spo2 was non-functional and did not produce any readings.Simulated vital signs read accurately, but the ecg waveform was noisy.There was also a black line across the lcd when the device was powered on.The evaluation showed that this complaint is confirmed, and the root cause of the reported issue is due to failure in the ecg connector board, spo2 board, or analog board.Board failure could occur due to excessive heat or dust, component failure, thermal stress, or due to normal wear and tear.Trending will continue to be monitored for this device, incidents, issues, and causes.

• 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: 22171421
• Report Number: 8030229-2025-05002
• Device Sequence Number: 9382771
• Product Code: MHX
• UDI-Device Identifier: 04931921113677
• UDI-Public: (01)04931921113677
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 06/09/2025

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-3552
• Device Catalogue Number: BSM-3552A
• 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: 03/03/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2020
• 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: NI.
• Patient Sex: Unknown