MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-9100A; VITAL SIGN MONITOR

Model Number	BSM-9100A
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the facility power went down and now the bedside monitor (bsm) is not working correctly.During a case in the cardiac surgery operating room, the bsm secondary display settings locked up and cannot be changed.With the bsm display being freeze up, the hospital staff took the cardiac surgery operating room out of service, cancelled the case and moved the patient.The staff rebooted the bsm and the secondary screen came back up.This also freed up the parameter options they were looking for.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 customer reported that the facility power went down and now the bedside monitor (bsm) is not working correctly.During a case in the cardiac surgery operating room, the bsm secondary display settings locked up and cannot be changed.With the bsm display being freeze up, the hospital staff took the cardiac surgery operating room out of service, cancelled the case and moved the patient.No consequence or impact to the patient was reported.
Event or Problem Description
The customer reported that the facility power went down and now the bedside monitor (bsm) is not working correctly.During a case in the cardiac surgery operating room, the bsm secondary display settings locked up and cannot be changed.With the bsm display being freeze up, the hospital staff took the cardiac surgery operating room out of service, cancelled the case and moved the patient.No consequence or impact to the patient was reported.
Additional Manufacturer Narrative
Details of the complaint on (b)(6) 2019, customer at (b)(6) center reported the bsm-9100a (mu-910ra sn: (b)(6) settings were locked and could not be changed.The unit had not been acting correctly since the power outage which occurred the other day.The second display was stuck on the splash screen and the settings were stuck for different parameters.Service requested troubleshooting/assistance.Service performed the screen came back up upon rebooting the unit, which also freed up the parameter options.Customer was advised on how to change the temperature unit.Investigation result the bsm warranty began 07/26/2014.The reported issue occurred after approximately 5 years at customer site.Review of device sap history found no previously reported issues with the unit.The root cause is determined to be power outage at the facility.Issue resolved upon rebooting the bsm and educating customer on how to change desired settings.This issue is not suspected to be caused by deficient device or 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.H6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

• Brand Name: BSM-9100A
• Common Device Name: VITAL SIGN 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: 8853148
• Report Number: 8030229-2019-00328
• Device Sequence Number: 319182
• Product Code: MHX
• UDI-Device Identifier: 00841983103391
• UDI-Public: 00841983103391
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K082785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2019
• Report Date (Section F): 09/27/2019

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-9100A
• Device Catalogue Number: MU-910RA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/27/2019
• Device Age: 62 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2019
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 09/27/2019
• 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: 09/27/2019