MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-2354A; VITAL SIGNS MONITOR

Model Number	BSM-2354A
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer reported that their bedside monitors (bsm) experienced intermittent communication loss with the central nurse's station (cns).No additional information on this event was available following three attempts at obtaining it from the reporter.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Device not returned.
Event or Problem Description
The biomedical engineer reported that their bedside monitors (bsm) experienced intermittent communication loss with the central nurse's station (cns).

• Brand Name: BSM-2354A
• Common Device Name: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan 161-8 560; JA 161-8560
• MDR Report Key: 6671668
• Report Number: 8030229-2017-00218
• Device Sequence Number: 1735624
• Product Code: MHX
• UDI-Device Identifier: 04931921101728
• UDI-Public: 04931921101728
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/27/2017
• Report Date (Section F): 06/27/2017

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-2354A
• Device Catalogue Number: BSM-2354A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/31/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2017
• Initial Report FDA Received Date: 06/27/2017
• 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: 06/27/2017