MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6501A; VITAL SIGNS MONITOR

Model Number	BSM-6501A
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Technical support (ts) suggested for the customer to check some things on the wlan box attached to the bsm.Ts suggested for him to change out the wlan box with a known working one.The customer will try these suggestion and reach out again if needed.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.
Event or Problem Description
The customer reported that the bedside monitor (bsm) is having intermittent communication loss (comm loss).There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the bedside monitor (bsm) was in intermittent comm loss at the central nurse's station (cns).Technical support (ts) suggested the customer change out the wlan box with a known working one.The customer was to try this and reach out again if needed.No patient harm was reported.Investigation summary: the customer checked to verify that the physical connection between the wlan pack and the bsm 6000 was seated properly.On 2/23/2022, the customer stated that they resolved the issue by resetting the wlan pack.The wireless lan station is an optional module that is connected to the bedside device as.Since the cause of the reported event was isolated to the setting of the wlan pack, service history for this facility was reviewed for issues related to qi-420p.Additionally, the service history was reviewed for the three-month period between 11/2021 to 01/2022 for related incidents.This was an isolated incident.There has been no recurrence of communication loss related to wlan.As a result, the probable cause is attributable to configuration and/or network related.There is no evidence of a qi-420p, bsm 6000, or cns malfunction.Comm loss/signal loss is an error message notifying the user of loss of network communication between the monitoring cns or rns and that of the monitored devices.The message appears on an individual "tile" on the cns, corresponding to the communication loss of the monitored device.Other related events that may cause the issue are accidentally turning off the device, or accidentally unplugging the network cable of the monitored device, or user error.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the cns: bsm: model #: ni.Serial #: ni.Wlan device: model #: ni.Serial #: ni.
Event or Problem Description
The customer reported that the bedside monitor (bsm) was in intermittent comm loss at the central nurse's station (cns).There was no patient injury reported.

• Brand Name: BSM-6501A
• Common Device Name: 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 13311596
• Report Number: 8030229-2022-02390
• Device Sequence Number: 4944285
• Product Code: MHX
• UDI-Device Identifier: 04931921103548
• UDI-Public: 04931921103548
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 04/11/2023

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-6501A
• Device Catalogue Number: MU-651RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2020
• 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; WLAN DEVICE
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native