MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-1733A; VITAL SIGNS MONITOR

Model Number BSM-1733A

Device Problems No Device Output (1435); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the spo2 stopped working on the bedside monitor (bsm).Qa and tech support contacted the customer for information on the unit but they have been unresponsive.It was unclear whether spo2 stopped working in the midst of monitoring a patient; or whether they were already monitoring other vitals for the patient on the unit, and discovered this issue when they tried to use the spo2 and found it did not work.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.A2: a6, b6: b7.D10: concomitant medical device.Attempt #: 1.(b)(6) 2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #: 2.(b)(6) 2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt # 3.01/09/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

Event Description

The biomedical engineer (bme) reported that the spo2 stopped working on the bedside monitor (bsm).Qa and tech support contacted the customer for information on the unit but they have been unresponsive.It was unclear whether spo2 stopped working in the midst of monitoring a patient; or whether they were already monitoring other vitals for the patient on the unit, and discovered this issue when they tried to use the spo2 and found it did not work.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the bedside monitor (bsm) stopped giving spo2 readings.It was unclear whether the spo2 stopped working while in patient use or was discovered when trying to first use it.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) stopped giving spo2 readings.It was unclear whether the spo2 stopped working while in patient use or was discovered when trying to first use it.No patient harm was reported.Investigation summary: the reported device, (bsm-1733a, sn: (b)(6)) was returned and evaluated.During evaluation of the device, nihon kohden repair center (nk rc) confirmed the reported issue.The spo2 computer board, a/msx-2013 (spo2 brd masimo), had an electrical failure, and was replaced.After the part was replaced, the device passed all post repair testing and evaluation, meeting specifications in all areas.The device was then shipped back to the customer, resolving the issue.The root cause was attributed to a component failure, possibly due to a power issue, such as a power outage or sudden surge in power at the facility, leading to damage to the sensitive component.Once the issue was resolved, no further issues related to this incident have been reported since.A review of the device history showed that this was the only issue found for this device at this facility, in the past three (3) years.A significant trend that would warrant any action and/or any corrective action has not been observed.Trending will continue to be monitored.The following fields contains no information (ni), as attempts to obtain the information were made, but not provided: attempt #1 01/02/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 01/04/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 01/09/2024 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

• Brand Name: BSM-1733A
• Type of Device: 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 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: 18585192
• MDR Text Key: 334779889
• Report Number: 8030229-2024-04062
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921111833
• UDI-Public: 4931921111833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BSM-1733A
• Device Catalogue Number: BSM-1733A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1