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

Model Number	BSM-3532A
Medical Device Problem Codes	No Device Output (1435); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the ecg will show for a little while, but then it will randomly stop showing anything at all on this bedside monitor (bsm).There are no error messages when this occurs.They have swapped out lead sets, but the only way to fix it is to reboot the bsm.However, even after that, it works for a little while before it stops working again.No patient harm was 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.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.Concomitant medical products: attempt #1 04/27/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 05/11/2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient and additional device information as requested.
Event or Problem Description
The biomedical engineer (bme) reported that the ecg will show for a little while, but then it will randomly stop showing anything at all on this bedside monitor (bsm).There are no error messages when this occurs.They have swapped out lead sets, but the only way to fix it is to reboot the bsm.However, even after that, it works for a little while before it stops working again.No patient harm was reported.
Additional Manufacturer Narrative
Details of the complaint: the biomedical engineer (bme) reported that the ecg will show for a little while, but then it will randomly stop showing anything at all on this bedside monitor (bsm).There are no error messages when this occurs.They have swapped out lead sets, but the only way to fix it is to reboot the bsm.However, even after that, it works for a little while before it stops working again.No patient harm was reported.Service requested / performed: the device, (bsm-3532a, serial number (b)(4)), was returned, decontaminated, cleaned, and evaluated.During evaluation we were able to confirm and duplicate the reported issue, after running the device on a simulator over a 5 (five) day period, for the error to be displayed.The unit was then sent to 208 for further processing.In this case a root cause was not determined, and the possible causes will be listed below the root cause section.Investigation conclusion: we were able to confirm and duplicate the reported issue, based on the evaluation of the device.Unfortunately, a root cause was not determined, however, it is likely the issue was due to damage (due to physical damage and/or wear and tear to the device).To resolve the issue, we shipped the customer a replacement device.Although a root cause was not determined, a list of the potential causes, are listed below.Potential causes: ecg issues are due to several potential causes, which include, but are not limited to the following: damaged issue: device damage/broken components, damaged buttons on control panel, damaged enclosures, broken cables/sockets, physical damage, due to the shipping process, droppage during installation, usage or transit, impacting internal components and/or wear and tear of the device and/or its components can lead to the reported issue.User errors: the use of incompatible software, or damaged hardware/leads, leads placed incorrectly and/or measurements being performed incorrectly, patient conditions such as: body movement, arrhythmia, and/or pulse wave is not detectable.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.Attempt #1: 04/27/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: 05/11/2023 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient and additional device information as requested.
Event or Problem Description
The biomedical engineer (bme) reported that the ecg will show for a little while, but then it will randomly stop showing anything at all on this bedside monitor (bsm).There are no error messages when this occurs.They have swapped out lead sets, but the only way to fix it is to reboot the bsm.However, even after that, it works for a little while before it stops working again.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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 16998207
• Report Number: 8030229-2023-03525
• Device Sequence Number: 6575161
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: 04931921113660
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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
• Date Returned to Manufacturer: 05/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2021
• 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