MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-3532A; VITAL SIGNS MONITOR

Model Number	BSM-3532A
Medical Device Problem Codes	Application Program Problem (2880); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 biomedical engineer (bme) reported that the bedside monitor (bsm) started flashing red and then it rebooted itself while monitoring a patient.The bme stated that they did a few tests with the bedside and it seems to be working but they want to send it in for inspection as a precaution.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) started flashing red then spontaneously rebooted itself while monitoring a patient.No patient harm or injury was reported.Investigation summary: the customer was provided with an exchanged device and sent the reported device in for evaluation.The reported software/startup issue was duplicated.Nihon kohden repair center (nk rc) reinstalled the software, initialized the device, and tested the device for over a week, with no software/startup issues observed.The device was tested, (per the operator's/service manual) and no issues were found with the device.The device was then subjected 24 (twenty-four) hours of extended testing, with no adverse effect, passing all tests and inspections, meeting specifications in all areas.The device was then dispositioned to nk's "used stock" inventory, as the customer was already provided with a replacement to resolve the issue.Based on the reported information, nk was able to confirm the event was due to a software issue, and the software was updated, which resolved the reported issue.A review of the device history determined this was an isolated incident.This was the only complaint found for this device and facility in the past 3 (three) years.A significant trend has not been observed.Trending will continue to be monitored for this device, incident issues, and causes.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 12/21/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 12/23/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 12/28/2021 emailed the customer via microsoft outlook for patient information: the customer replied, stating there were no other devices connected to this bsm at the time of the event.The customer did not provide the requested patient information.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) started flashing red then spontaneously rebooted itself while monitoring a patient.No patient harm was reported.

• Brand Name: BSM-3532A
• Common Device Name: VITAL SIGNS 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 13261960
• Report Number: 8030229-2022-02398
• Device Sequence Number: 1519051
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: 04931921113660
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K080342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2023

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-3532A
• Device Catalogue Number: BSM-3532A
• 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: 12/20/2021
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• 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