MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6700A; VITAL SIGN MONITOR

Model Number	BSM-6700A
Medical Device Problem Code	Application Program Problem: Parameter Calculation Error (1449)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer is considering upgrading the software to resolve the issue.The unit was in use on patients, but no patient harm was reported.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 after setting each ibp parameter on the bedside monitor (bsm) prior to reaching the calculation step, they realized that the mean of the parameters hadn't stayed set and they would sometimes have to reset the parameter prior to the calculation step.
Event or Problem Description
The customer reported that after setting each ibp parameter on the bedside monitor (bsm) prior to reaching the calculation step, they realized that the mean of the parameters hadn't stayed set and they would sometimes have to reset the parameter prior to the calculation step.
Additional Manufacturer Narrative
Details of complaint: the customer called to report that their nurses were having issues with co average settings not sticking.The customer reported that after setting each ibp parameter on the bedside monitor (bsm) prior to reaching the calculation step, they realized that the mean of the parameters hadn't stayed set and they would sometimes have to reset the parameter prior to the calculation step.The issue was resolved by upgrading the site to the new gui from 0240.No patient harm was reported.Service requested / performed: troubleshooting.Investigation summary: the overall risk score is medium.The root cause of this issue is not related to a deficiency or non-conformance of an nk device.The gui used when the issue was reported was interfering with the process used at the customer's facility.The new gui resolved the issue.As this issue is not a result of a deficiency or non-conformance of an nk device, root cause analysis is not performed and capa is not required.

• Brand Name: BSM-6700A
• Common Device Name: VITAL SIGN MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• MDR Report Key: 8800840
• Report Number: 8030229-2019-00302
• Device Sequence Number: 11587035
• Product Code: MHX
• UDI-Device Identifier: 00841983101045
• UDI-Public: 00841983101045
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K080342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021
• Report Date (Section F): 07/17/2019

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-6700A
• Device Catalogue Number: MU-671RA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/21/2019
• Device Age: 100 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 07/22/2021
• 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: 07/17/2019