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
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.
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
• MDR Report Key: 11971379
• Report Number: 2080783-2021-00328
• Device Sequence Number: 11106631
• Product Code: MHX
• UDI-Device Identifier: 04931921113677
• UDI-Public: 04931921113677
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/09/2021
• Report Date (Section F): 06/09/2021

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/13/2021
• Device Age: 17 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CNS
• Date Report Sent to FDA: 06/09/2021