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	02/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported this bedside monitor (bsm) was showing an sd card failure symbol on the screen and randomly rebooting itself.This was in use with a patient at the time, but there was no injury or harm.Bme took the bsm out of service, and the sd card failure symbol was still there even after rebooting the device multiple times.They would like to send the device in 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.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2, a3b, a4 b6, b7., attempt # 1: 02/13/2024 emailed the bme for all patient information and concomitant medical device: no reply was received.Attempt # 2: 02/16/2024 emailed the bme for all patient information and concomitant medical device: the bme was able to provide some patient information and the concomitant medical device.Additional device information: d10 concomitant medical device: the following device wsd used in conjunction with the bsm: cns-6801a.Model #: pu-681ra.Serial #: (b)(6).Device manufacturer data: 04/04/2022.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (bme) reported this bedside monitor (bsm) was showing an sd card failure symbol on the screen and randomly rebooting itself.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported this bedside monitor (bsm) was showing an sd card failure symbol on the screen and randomly rebooting itself.This was in use with a patient at the time, but there was no injury or harm.Bme took the bsm out of service, and the sd card failure symbol was still there even after rebooting the device multiple times.They would like to send the device in for repair.Investigation summary: the nihon koden repair center evaluated the bsm and the reported issue.It was confirmed and duplicated, and the unit requires a new sd card replacement, initialization, and software reinstallation.A definitive root cause was not determined.Based on the available information, the most probable root cause was due to corrupt files on the unit, which was causing the device to reboot.The unit has been successfully repaired and shipped back to the customer.Several potential causes of sd card related issues have been identified, including sd card corruption, sd card failure, improper insertion of the sd card, and improper storage management.The most common causes of sd card failure and corruption are wear and tear of the sd card and improper or unexpected shutdown.Moisture, bending or dropping the sd card, storing the sd card in a high-temperature environment, or in direct sunlight may also cause sd card failure.Improper sd card seating or using unsanctioned sd cards other than those provided by nihon kohden may also cause the error message and icon to appear as the device is unable to properly read the sd card.A review of the reported device's serial number does not reveal additional related complaints.The complaint history review of the customer's account does not reveal trends for similar complaints.Nihon kohden will continue to monitor and trend similar complaints.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: attempt # 1: 02/13/2024 emailed the bme for all patient information and concomitant medical device: no reply was received.Attempt # 2: 02/16/2024 emailed the bme for all patient information and concomitant medical device: the bme was able to provide some patient information and the concomitant medical device.Additional device information: d10 concomitant medical device: the following device wsd used in conjunction with the bsm: cns-6801a.Model #: pu-681ra.Serial #: (b)(4).Device manufacturer data: 04/04/2022.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (bme) reported this bedside monitor (bsm) was showing an sd card failure symbol on the screen and randomly rebooting itself.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: 18825707
• Report Number: 8030229-2024-04170
• Device Sequence Number: 19601959
• Product Code: MHX
• UDI-Device Identifier: 04931921113691
• UDI-Public: 04931921113691
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 05/01/2024

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: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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; CNS
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White