MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6501A; VITAL SIGNS MONITOR

Model Number	BSM-6501A
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer systems analyst reported that the co hemo readings displayed on the bedside monitor (bsm) and sent to epic, their 3rd party emr system, differ when viewed in epic.It is unclear what is causing this issue.Co reading in nk and epic at 4:12 pm est: nk co 5.4.Epic co 7.7.(b)(4) just transfers the data and does not alter the historical data being sent to epic.No patient harm was reported.Additional device information: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.
Event or Problem Description
The customer systems analyst reported that the co hemo readings displayed on the bedside monitor (bsm) and sent to epic, their 3rd party emr system, differ when viewed in epic.It is unclear what is causing this issue.Co reading in nk and epic at 4:12 pm est: nk co 5.4.Epic co 7.7.(b)(4) just transfers the data and does not alter the historical data being sent to epic.No patient harm was reported.

• Brand Name: BSM-6501A
• Common Device Name: VITAL SIGNS 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: 13262041
• Report Number: 2080783-2022-02333
• Device Sequence Number: 11952228
• Product Code: MHX
• UDI-Device Identifier: 04931921103548
• UDI-Public: 04931921103548
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2022
• Report Date (Section F): 01/14/2022

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-6501A
• Device Catalogue Number: MU-651RA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/17/2021
• Device Age: 58 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/14/2022