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	05/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the display screen on the bedside monitor (bsm) was going white intermittently.The device was in use on a patient, however no patient harm was reported.The bme will be sending the device in for repair.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 biomedical engineer reported that the display screen on the bedside monitor (bsm) was going white intermittently.
Event or Problem Description
The biomedical engineer reported that the display screen on the bedside monitor (bsm) was going white intermittently.
Additional Manufacturer Narrative
H10: additional narrative: on (b)(6) 2018, (b)(6) reported the bedside monitor (bsm-2354a sn:(b)(6)) had intermittent white screen.Service requested repair/exchange.Service performed nka repair center evaluation: unit was cleaned and under evaluation.We also visual inspected the labels.That matched with the unit.The reported problem "white screen intermittently" was duplicated.We troubleshooted the bedside and encountered other issue such as bad readings and waveform.On ecg and resp.Wanted to replace analog board (ur-3875) but we could not repair at this time because analog board (ur-3875) was out of stock.However, we are unable to repair the lcd at this time due to part was discontinued.We recommends customer for an exchange bedside.Please contact customer and advise for an exchange.Investigation result the bsm warranty began 07/07/06, which is almost 12 years prior to the reported issue.The warranty ended on 07/07/11.A review of device history found no previously reported issues with the unit.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.Nka repair center confirmed the white screen and also found ecg and respiration waveforms were found to be bad.Evaluation of the unit suspected failure of the lcd and analog board.Per bsm-2300a series service manual, a maintenance check should be performed once every six months.A maintenance check sheet is included in the service manual, which includes checking the display and vital sign parameters.Customer's maintenance information for this unit is not available.There is no sap record of nka servicing performed on this unit.The bsm-2354a model was discontinued on 08/03/11 in mbg-110308a due to the introduction of the bsm-6000 series monitor.Support for the unit continued for a minimum period of seven years.The issue occurred well beyond the warranty period and product discontinuance, and near the end of support period.Due to unavailability of parts, unit could not be repaired.Due to the age and condition of the unit, suspected root cause is maintenance needed.This issue is not suspected to be caused by deficient design.Corrected information: g4.Date received by manufacturer: should be 05/01/2018 not 05/03/2018 as listed on mdr initial report.

• 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: 7555484
• Report Number: 8030229-2018-00178
• Device Sequence Number: 144141
• 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): 08/12/2019
• Report Date (Section F): 08/12/2019

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: 08/14/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/09/2019
• Device Age: 143 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2019
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 08/12/2019
• 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: 08/12/2019