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

Model Number	BSM-2354A
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit was sent in for repair and cleaned and evaluated.The reported problem was duplicated.The unit was powered on.Tapping on the screen caused the lcd to fade out.Nihon kohden was unable to repair the bsm because a replacement lcd was not currently available, so the customer will be provided with an exchanged unit to resolve the issue.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the display screen on the bedside monitor (bsm) was intermittently going white.
Event or Problem Description
The biomedical engineer (bme) reported that the display screen on the bedside monitor (bsm) was intermittently going white.
Additional Manufacturer Narrative
Details of the complaint on (b)(6) 2018, customer at (b)(6) hospital reported the bedside monitor (bsm-2354a sn: (b)(6) had issues with the screen going in and out.The screen would be working but then would fade out and go to a white screen.If he taps on the screen, it will flicker but will still go to a white screen.Service requested evaluation: service performed unit was cleaned and under evaluation.We also visual inspected the labels that matched with the unit.The reported problem "this bsm has an issues with the screen going in and out" was duplicated.We powered on and tapped the on the screen, the lcd was faded out.We are unable to repair this bsm due to the lcd was not available at this time.Exchange was processed.Investigation result the bsm warranty began 07/07/2006.Issue was reported after 12 years at customer facility.Per nkc dhr (attached), the unit has had no history of ncmr, deviation, or capa during manufacturing of the device.The device has not been refurbished and there were no discrepancies or unusual findings before device release that might relate to the reported issue.Review of device sap history found previously reported issues with the unit: (1) 300092568 reported 08/04/2017 in which unit was reported to have damage.Parts were requested for customer to perform repairs.(2) 300098328 reported 09/22/2017 in which unit's screen was reported to dim intermittently.Nka evaluation was unable to duplicate the reported issue.A precautionary replacement of the lcd was recommended however due to lack of customer response, the unit was returned unrepaired.Issue with lcd display was reported shortly after device damage, however whether the damage contributed to lcd failure could not be confirmed.The bsm-2354 model was discontinued on 08/03/2011 in mbg-110308a due to the introduction of bsm-6000 series monitor.Support for the unit continued for a minimum period of seven years.The issue was reported well beyond the warranty period and product discontinuance, and at the end of promised support period.Due to a lack of parts available, the lcd could not be replaced.The root cause is determined to be continued use of the unit past its expected serviceable period.This issue is not suspected to be caused by deficient design.Additional information: b4.Date of this report.F6.Date user facility/importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? additional information.H3.Device evaluated by manufacturer.H6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

• 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: 7871295
• Report Number: 8030229-2018-00361
• Device Sequence Number: 1964240
• 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,Followup
• Report Date (Section B): 10/17/2019
• Report Date (Section F): 10/17/2019

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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/16/2019
• Device Age: 147 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT APPLICABLE
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/17/2019