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.
Additional Manufacturer Narrative
Details of complaint: the customer reported that they installed four new wireless bedside monitors (bsms) and they were randomly going into comm loss.The customer stated that when in comm loss, the moment the units were taken out of the room, their communication would be restored.No patient harm or injury was reported.Investigation summary: nihon kohden technical support (nk ts) performed troubleshooting steps and informed the biomedical engineer to contact the facility's it department as the issue is most likely an interference problem in the rooms with existing facility equipment.The root cause is determined to be the facility's network environment.The most likely cause of interference is lack of network coverage to the room, or equipment interference.
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; 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: 11220088
• Report Number: 8030229-2021-00026
• Device Sequence Number: 19578814
• Product Code: MHX
• UDI-Device Identifier: 04931921111956
• UDI-Public: 4931921111956
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K102376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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-1773A
• Device Catalogue Number: BSM-1773A
• 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: 12/23/2020
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 01/23/2021
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown