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
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.Hl7 just transfers the data and does not alter the historical data being sent to epic.No patient harm was reported.
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.Hl7 just transfers the data and does not alter the historical data being sent to epic.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 when additional information becomes available.Additional device information: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.
Additional Manufacturer Narrative
Details of complaint: the customer systems analyst reported a discrepancy between the co hemo readings displayed on the bedside monitor (bsm) and that of the electronic medical records (emr) system, which was sent to epic.No patient harm was reported.Investigation summary: the cause of the discrepancy was that epic, an emr, was not configured properly to reflect the correct hemo trend values.It was configured to display vitals.This issue is to be addressed by epic as they can remap the values to match the customer's needs.There is no evidence of an nk device malfunction or improper use of nk devices.Further action is not warranted.The root cause is related to third-party product.
Event or Problem Description
The customer systems analyst reported a discrepancy between the co hemo readings displayed on the bedside monitor (bsm) and that of the electronic medical records (emr) system.

• 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
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 13262011
• Report Number: 8030229-2022-02333
• Device Sequence Number: 11153468
• Product Code: MHX
• UDI-Device Identifier: 04931921103548
• UDI-Public: 04931921103548
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown