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

Model Number	BSM-2354A
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nurse reported that the display screen on the bedside monitor (bsm) was intermittently going white.Tapping on the side of the unit temporarily resolved the issue, however it was occurring more frequently.They sent the unit in for repair and it is currently awaiting evaluation.The unit was not in use on a patient at the time.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.
Event or Problem Description
The nurse reported that the display screen on the bedside monitor (bsm) was intermittently going white.
Additional Manufacturer Narrative
Corrected data: device evaluated by manufacturer, additional manufacturer narrative.Additional information: type of report: follow up, type of report: follow up, if follow-up, what type?: additional information/correction.Event problem and evaluation codes.The nurse reported that the display screen on the bedside monitor (bsm) was intermittently going white.Tapping on the side of the unit temporarily resolved the issue, however it was occurring more frequently.They sent the unit in for repair.The unit was not in use on a patient at the time.The unit was cleaned and evaluated.The reported problem of "screen will go white" and "communication loss" could not be duplicated through testing, trouble shooting and extended operation of the device.However, it was recommended by nihon kohden that a new network card be purchased to resolve "comm loss" issue.Evaluation also revealed that the touchscreen is worn out and needs to be replaced.

• 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: 6867071
• Report Number: 8030229-2017-00308
• Device Sequence Number: 460960
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2017
• Report Date (Section F): 09/14/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/18/2017
• Device Age: 108 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2017
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 11/03/2017
• 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: 09/14/2017