MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-1773A; BEDSIDE MONITOR, NK SPO2

Model Number	BSM-1773A
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that they have installed four new wireless bedside monitors (bsm) and they would randomly go into communication loss.They would work for most of the time and then randomly get communication loss.The customer stated that when they see communication loss, the moment they take the units out of the room, its communication would be restored.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.
Event or Problem Description
The customer reported that they have installed four new wireless bedside monitors (bsm) and they would randomly go into communication loss.They would work for most of the time and then randomly get communication loss.The customer stated that when they see communication loss, the moment they take the units out of the room, its communication would be restored.No patient harm was reported.

• Brand Name: BSM-1773A
• Common Device Name: BEDSIDE MONITOR, NK SPO2
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 11220350
• Report Number: 2080783-2021-00026
• Device Sequence Number: 4497861
• Product Code: MHX
• UDI-Device Identifier: 04931921111956
• UDI-Public: 4931921111956
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/22/2021
• Report Date (Section F): 01/22/2021

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-1773A
• Device Catalogue Number: BSM-1773A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/23/2020
• Device Age: 68 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/22/2021