MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-3532A; VITAL SIGNS MONITOR

Model Number	BSM-3532A
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the bedside monitor (bsm) shows in communication loss (comm loss) on the central nurse's station (cns).Technical support (ts) is working with the customer to resolve the reported issue.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.Additional model information: 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: ni.
Event or Problem Description
The customer reported that the bedside monitor (bsm) shows in communication loss (comm loss) on the central nurse's station (cns).
Additional Manufacturer Narrative
Details of complaint: the customer reported that the bedside monitor (bsm) shows in communication loss (comm loss) on the central nurse's station (cns).Technical support (ts) is working with the customer to resolve the reported issue.There was no patient injury reported.Investigation summary: during follow-up with the customer, customer indicated that the communication loss issue was due to the network cable filter.The customer did not provide additional information.Based on the available information, a definitive root cause could not be identified.However, it is possible that staff or personnel may have accidentally unplugged the network cable of the device.Communication loss issues may also occur due to damaged and/or faulty network cables and hit.These components may fail due to wear and tear from normal use, or due to power fluctuations.The issue is related to the cable used with the nk device.Available information does not suggest that there was a malfunction of the cns device.No corrective actions will be performed at this time.Additional model 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: ni.Manufacturer references # 300286525 - 134347 follow up 001.
Event or Problem Description
The customer reported that the bedside monitor (bsm) shows in communication loss (comm loss) on the central nurse's station (cns).

• Brand Name: BSM-3532A
• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 14031769
• Report Number: 8030229-2022-02701
• Device Sequence Number: 12334133
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: 04931921113660
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 07/06/2022

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-3532A
• Device Catalogue Number: BSM-3532A
• 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: 03/08/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• 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; CNS
• Patient Sex: Unknown