MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION LIFE SCOPE VS; VITAL SIGN 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	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that this bedside monitor (bsm-3500) is taking inaccurate ecg readings.According to the customer, the ecg will swing from a low 15 bpm to 130.The customer will send in the unit to be repaired.There was no patient injury 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.
Event or Problem Description
The customer reported that this bedside monitor (bsm-3500) is taking inaccurate ecg readings.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that this bedside monitor (bsm-3500) is taking inaccurate ecg readings.According to the customer, the ecg will swing from a low 15 bpm to 130.The customer will send in the unit to be repaired.There was no patient injury reported.Investigation summary: based on the evaluation of the returned device, this complaint is not confirmed.A definitive root cause of the reported issue could not be determined.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: d10 (b)(6) 2024 a phone call was made in an attempt to gather device information; a voice mail was left for (b)(6) requesting a return call with the device information.Attempt # 2: (b)(6) 2024 a phone call was made in an attempt to gather device information; a voice mail was left for (b)(6) requesting a return call with the device information.Attempt # 3: (b)(6) 2024 a phone call was made in an attempt to gather device information; a voice mail was left for (b)(6) requesting a return call with the device information.
Event or Problem Description
The customer reported that this bedside monitor (bsm-3500) is taking inaccurate ecg readings.There was no patient injury reported.

• Brand Name: LIFE SCOPE VS
• Common Device Name: VITAL SIGN 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: 20604774
• Report Number: 8030229-2024-04489
• Device Sequence Number: 7393605
• Product Code: MHX
• UDI-Device Identifier: 04931921113677
• UDI-Public: (01)04931921113677
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 01/20/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.; NI.
• Patient Sex: Unknown