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

Model Number BSM-1733A

Device Problems Device Displays Incorrect Message (2591); Data Problem (3196)

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

Event Date 02/10/2023

Event Type  malfunction  

Event Description

The customer reported that when they pulled the transport monitor and it was showing a different patient.There was no patient injury reported.

Manufacturer Narrative

The customer reported that when they pulled the transport monitor and it was showing a different patient.In response to that, the gateway service was rebooted.According to the customer, the issue was resolved in house.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.

Manufacturer Narrative

Details of complaint: the customer reported that when they pulled the transport monitor and it was showing a different patient.In response to that, the gateway service was rebooted.According to the customer, the issue was resolved in house.There was no patient injury reported.Investigation summary: the cause of the issue could not be identified.Incorrect patient being displayed may be caused by incomplete transfers, improper discharge, and improper removal of the transport monitor from the bedside monitor.These events may cause data corruption or may cause inconsistency in the data between the server and the bedside monitor.The operator's manual contains instructions on how to properly perform patient transfer, transport monitor removal, and patient discharge.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 03/14/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have this information.B6 attempt # 1: 03/14/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have this information.B7 attempt # 1: 03/14/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have this information.D10 attempt # 1: 03/14/2023 emailed the customer via microsoft outlook for device information: the customer replied by stating; i do not have this information.The following fields are not available (n/a) to this report: h4 device manufacturer date additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow up, what type? h4 device manufacturer date h10 additional manufacturer narrative manufacturer references # (b)(4) follow up 001.

Event Description

The customer reported that when they pulled the transport monitor and it was showing a different patient.There was no patient injury reported.

• 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: 16591840
• MDR Text Key: 311826728
• Report Number: 8030229-2023-03447
• 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,Followup
• Report Date: 06/27/2023

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
• Device Operator: Health Professional
• Device Model Number: BSM-1733A
• Device Catalogue Number: BSM-1733A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2018
• 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