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

Model Number	BSM-2354A
Date of Event	08/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nurse reported that the device screen on the bedside monitor (bsm) is completely blank black.Issue started happening (b)(6) 2016.Device was switched out with a functional device.Issue occurred while a patient was being monitored.No patient harm reported.A second loaner device was provided to the nurse to replace this malfunctioning loaner device until the original device was repaired and returned.The original loaner device was returned to nihon kohden and evaluated.In the evaluation, all steps per maintenance check sheet were completed.
Event or Problem Description
The nurse reported that the device screen on the bedside monitor (bsm) is completely blank black.

• 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, 161-8 560; JA 161-8560
• MDR Report Key: 6966966
• Report Number: 8030229-2017-00343
• Device Sequence Number: 1324701
• Product Code: MHX
• UDI-Device Identifier: 04931921101728
• UDI-Public: 04931921101728
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2017
• Report Date (Section F): 10/20/2017

1 Device 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/30/2016
• Device Age: 142 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Date Report Sent to FDA: 10/20/2017