MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-3552A; VITAL SIGN MONITOR

Model Number	BSM-3552A
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the bedside monitors (bsms) recently stopped being displayed at the central nurse's station (cns).According to the customer, both units show comm loss on the cns.
Additional Manufacturer Narrative
The customer reported that the units recently stopped being displayed at the cns.According to the customer, both units show comm loss on the cns.The customer was not able to provide the sn for the other bsm unit.Technical service asked the customer to make sure that the units were powered on.The customer stated that both units had been powered down; however, once the customer turned the units on, the comm loss message went away.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 Manufacturer Narrative
Details of complaint: the customer reported that the units recently stopped being displayed at the cns.According to the customer, both units show comm loss on the cns.The customer was not able to provide the sn for the other bsm unit.Technical service asked the customer to make sure that the units were powered on.The customer stated that both units had been powered down; however, once the customer turned the units on, the comm loss message went away.There was no patient injury reported.Investigation summary: communication loss is an error message notifying user of loss of network communication between the monitoring devices and the cns.The error message could be easily detected by the user, and they would be able to perform necessary monitoring adjustments which mitigates the issue.With the information available it is reasonable to determine root cause of communication loss were powered off devices.Communication loss may occur due to issues with the customer's network environment.Network access point overload may cause an unstable network connection and may cause devices to randomly drop connection.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6.Attempt # 1: 05/17/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 05/19/2021 emailed the customer via microsoft outlook for patient information: the customer replied by simply stating; hi i am a biomed and not affiliated with the clinical side of this particular case.B6 attempt # 1: 05/17/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 05/19/2021 emailed the customer via microsoft outlook for patient information: the customer replied by simply stating; hi i am a biomed and not affiliated with the clinical side of this particular case.B7 attempt # 1: 05/17/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 05/19/2021 emailed the customer via microsoft outlook for patient information: the customer replied by simply stating; hi i am a biomed and not affiliated with the clinical side of this particular case.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.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h10 additional manufacturer narrative.Manufacturer references # (b)(4).
Event or Problem Description
The customer reported that the bedside monitors (bsms) recently stopped being displayed at the central nurse's station (cns).According to the customer, both units show comm loss on the cns.

• Brand Name: BSM-3552A
• Common Device Name: VITAL SIGN 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: 11971373
• Report Number: 8030229-2021-00328
• Device Sequence Number: 11680870
• Product Code: MHX
• UDI-Device Identifier: 04931921113677
• UDI-Public: 04931921113677
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/21/2023

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-3552A
• Device Catalogue Number: BSM-3552A
• 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: 05/13/2021
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2019
• 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