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

Model Number	BSM-3572A
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that this bedside monitor (bsm) was constantly rebooting.There were some signs of physical damage - cracks on the front enclosure.No patient harm was reported.Investigation summary: nihon kohden (nk) was able to confirm that the rebooting of the device issue was due to a malfunctioning main digital board and found a bad sd card.Nk also confirmed the physical damage to the front enclosure case of the device (as a hole and crack were found in the device).Nk's repair center replaced the parts (main digital board, sd card, and front case), and the bsm device passed post-repair testing and operated as intended.Unfortunately, a definitive root cause of how the damage occurred cannot be determined, as the issue is user dependent.It is unclear if the proper cleaning techniques were used in the past either; however, the customer indicated they were using the proper cleaning techniques.Based on a review of the available information, it is possible the damaged components (noted above) could have been damaged due to fluid spill into the device (from cleaning solution or other chemicals) and/or due to physical damage from an impact to the device, which can cause damage to the device or its internal components and lead to the reported startup and boot looping issues.Other known potential causes are software/ network/connectivity/environmental/it.Further investigation and testing of the damaged cracking enclosure/plastic casing is not currently required.Nk will continue to trend and monitor this device, incident issues, and causes.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6.B6.B7.D10.Attempt # 1: 06/15/2023.Emailed the bme for patient information and concomitant medical device: no reply was received.Attempt # 2: 06/20/2023.Emailed the bme for patient information and concomitant medical device: the bme responded: this issue was happening randomly and not to any specific patient or station.Unknown patient information and cns.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the bsm: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (bme) reported that this bedside monitor (bsm) was constantly rebooting.No patient harm was reported.

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17302146
• Report Number: 8030229-2023-03648
• Device Sequence Number: 7061387
• Product Code: MHX
• UDI-Device Identifier: 04931921113691
• UDI-Public: 04931921113691
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 07/11/2023

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
• Date Returned to Manufacturer: 06/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2020
• 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: CNS.
• Patient Sex: Unknown