MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-3572A; VITAL SIGN MONITOR

Model Number	BSM-3572A
Medical Device Problem Codes	Output Problem (3005); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the bedside monitor (bsm) kept rebooting randomly.Customer was not able to see if there were any error messages because the device goes black and then reboots and continues to monitor like normal after 1/2 minutes and then repeats this same issue again.No patient harm reported.Customer will send the device to nihon kohden repair center for repair.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 the bedside monitor (bsm) kept rebooting randomly.Customer was not able to see if there were any error messages because the device goes black and then reboots and continues to monitor like normal after 1/2 minutes and then repeats this same issue again.No patient harm reported.Customer will send the device to nihon kohden repair center for repair.
Event or Problem Description
The customer reported that the bedside monitor (bsm) kept randomly rebooting.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the bedside monitor (bsm) kept randomly rebooting.The device was sent in for evaluation.No patient harm or injury was reported.Investigation summary: during the evaluation of the device, the reported issue was duplicated and confirmed.When the unit was rebooting, a loud ding was observed.A component was found to be damaged due to wear and tear.The main digital board, ur-40905, bsm-3500a (qty 1), was replaced to resolve the issue.The unit was tested, per the operator's/service manual and completed 24 (twenty-four) hours of extended testing, meeting specifications in all areas post repairs.The device was then shipped back to the customer.Nihon kohden repair center (nk rc) was able to confirm that the reported issue was due to a defective/damaged main digital board, which can lead to the reported issue.Although a root cause of how the damage occurred was not determined, it is possible the reported issues were due to damage from wear and tear from normal use of the device and/or physical damage, mishandling, or customer abuse.Main digital boards are expected to become damaged over time, due to normal use and degradation.A device and facility complaint history review indicated this is an isolated incident.Moreover, a significant trend has not been identified that would suggest any issues in design or manufacturing or warrant any further corrective action.Trending will continue to be monitored for this device, incident issues, and causes.

• Brand Name: BSM-3572A
• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 15936888
• Report Number: 8030229-2022-03217
• Device Sequence Number: 6200634
• Product Code: MHX
• UDI-Device Identifier: 04931921113691
• UDI-Public: 04931921113691
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2023

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-3572A
• Device Catalogue Number: BSM-3572A
• 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: 11/14/2022
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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