MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6301A; VITAL SIGNS MONITOR

Model Number BSM-6301A

Device Problems Erratic or Intermittent Display (1182); Intermittent Communication Failure (4038)

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

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

The customer reported the bedside monitor (bsm) would randomly disconnect from the central nurses station (cns).There was no error message; the tile would go blank for a few seconds, and the vitals would return.They tried rebooting the cns and the bsm, but the issue persisted.Technical support (ts) found history on this device on ticket 164025 on 02/08/2023, with a similar complaint.Ts asked the customer to collect logs from the bsm and the cns for further investigation.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 contain no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6, b6 - b7, d10.Attempt # 1: 01/23/2024 emailed the customer for all information in the ni list above: no reply was received.Attempt # 2: 01/30/2024 emailed the customer for all information in the ni list above: the customer replied the patient information is unknown.Attempt # 3: 02/08/2024 emailed the customer for the concomitant medical device: no reply was received.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 Description

The customer reported the bedside monitor (bsm) would randomly disconnect from the central nurses station (cns).There was no error message; the tile would go blank for a few seconds, and the vitals would return.No patient harm was reported.

Manufacturer Narrative

Details of the complaint: the customer reported the bedside monitor (bsm) would randomly disconnect from the central nurses station (cns).There was no error message; the tile would go blank for a few seconds, and the vitals would return.They tried rebooting the cns and the bsm, but the issue persisted.Technical support (ts) found history on this device on ticket (b)(4) on (b)(6) 2023, with a similar complaint.Ts asked the customer to collect logs from the bsm and the cns for further investigation.No patient harm was reported.Investigation summary: we received an additional report that when the blank phenomena happened on the cns, an error message was displayed on the cns.Nkc analyzed the logs of the cns and the settings of each bedside monitor (bsm).Which found the following inconsistent settings across the network; protocol, available alarm types, and arrythmia type.If the system settings of all devices connected to the hospital network do not match, the reported error message will be displayed.Nkc recommended checking and unifying the settings on each bedside monitor.On (b)(6) 2024, the customer responded that when they disassociated the room from the particular tile, rebooted the remote network station (rns), and then re-associated the room back to the tile.Communication loss on the tile was observed.The customer changed er room 4 to a different tile and added er room 5 in its place.It was stated that the communication loss did not return since the change.A review of historical data from (b)(6) 2022 to (b)(6) 2024 showed four reported mu-600 systems experiencing issues with random and intermittent blank tile.Trending will continue to be monitored for this device, incidents, issues, and causes.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the bsm: cns: model #: ni serial (b)(6) device manufacturer data: ni unique identifier (udi) (b)(4) returned to nihon kohden: na rns: model #: ni serial (b)(6) device manufacturer data: ni unique identifier (udi) (b)(4) returned to nihon kohden: na additional information: b4 date of this report d10 concomitant medical device g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h11 additional manufacturer narrative.

Event Description

The customer reported the bedside monitor (bsm) would randomly disconnect from the central nurses station (cns).There was no error message; the tile would go blank for a few seconds, and the vitals would return.No patient harm was reported.

• Brand Name: BSM-6301A
• 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 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: 18689422
• MDR Text Key: 336406398
• Report Number: 8030229-2024-04147
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: 04931921103517
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

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
• Device Operator: Health Professional
• Device Model Number: BSM-6301A
• Device Catalogue Number: MU-631RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2011
• 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
• Treatment: CNS; CNS; RNS