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

Model Number	BSM-3532A
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	10/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the nibp readings are intermittently producing the wrong bp readings.There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported that the nibp readings are intermittently producing the wrong bp readings.According to the customer, the user says that this has been happening for a while now; however, biomed is unable to duplicate the issue.The customer stated that when the issue happens, the user reboots the device and it works normally again.Biomed advised the user to not reboot the unit next time it happens and to reach out to them so that they can take a look.Biomed thinks it is possible that this is a user error or a bad board.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.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the nibp module for the bedside monitor (bsm) was intermittently producing incorrect bp readings.The biomedical engineer was unable to duplicate the issue.Rebooting the device would temporarily resolve the issue.No patient harm or injury was reported.Investigation summary: despite follow up attempts, no further information was reported, related to this issue.Nihon kohden (nk) was unable to confirm the reported issue, based on the available information.As such, a root cause cannot be determined.The device was not returned for evaluation, and further information is not available.However, the customer's bme suspected the issue was possibly due to a user-related error or a bad board.Variables such as incorrect cuff placement and incorrect patient preparation are known to affect bp readings.Although a definitive root cause could not be determined, we have identified several potential causes of nibp issues: device damage/broken components, a broken red nibp socket, physical damage impacting internal components (pump, dpu, power bd, digital bd), nibp circuit failure, pump failure, a malfunctioning/stuck solenoid, and wear and tear of the nibp components and/or device.Also, user errors, such as the use of an incompatible cuff/hose/cables, the cuff is wrapped too tightly or loosely, the hose or line is not connected properly, a bent hose, the nibp is performed concurrently with ibp measurement, patient conditions such as, body movement, arrhythmia, used while under spinal anesthesia during cpr, the pulse wave is not detectable.During review of the device and facility's history, this complaint for this issue was found to be the only one in the last 3 years.As such, a significant trend was not identified.Trending will continue to be monitored for this device, incident issues, and causes.Attempt # 1: 11/03/2022 emailed the customer via microsoft outlook for all information in the ni list: no reply was received.Attempt # 2: 11/15/2022 emailed the customer via microsoft outlook for all information in the ni list: no reply was received.Attempt # 3 11/17/2022 emailed the customer via microsoft outlook for all information in the ni list: no reply was received.
Event or Problem Description
The customer reported that the nibp module for the bedside monitor (bsm) was intermittently producing incorrect bp readings.There was no patient injury 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: 15823114
• Report Number: 8030229-2022-03185
• Device Sequence Number: 6157043
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: 04931921113660
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/01/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 07/22/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• 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.; NI.
• Patient Sex: Unknown