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

Model Number	BSM-2354A
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reports that the connection on the bedside monitor is going bad causing the screen to fade to white.If the left side of the monitor is tapped or squeezed the connection gets interrupted.The biomed resolved the issue by applying stabilant to the connections and by cinching the two screws down extra tight.The biomedical engineer requested the part number to order a few lcds but the order was never placed.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reports that the connection on the bedside monitor is going bad causing the screen to fade to white.If the left side of the monitor is tapped or squeezed the connection gets interrupted.

• Brand Name: BSM-2354A
• Common Device Name: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• MDR Report Key: 6301071
• Report Number: 8030229-2017-00030
• Device Sequence Number: 18967897
• Product Code: MHX
• UDI-Device Identifier: 04931921101728
• UDI-Public: 04931921101728
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/13/2017
• Report Date (Section F): 02/03/2017

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: 01/13/2017
• Device Age: 112 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 02/03/2017
• 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: 02/03/2017