MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-1773A; BEDSIDE MONITOR, NK SPO2

Model Number	BSM-1773A
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nurse reported that during a surgery there was a discrepancy between the bedside monitor (bsm) and their electronic medical record (emr).The nurse reported that the discrepancy was between the saturation of peripheral oxygen (spo2) and electrocardiogram (ecg) heart rate which is off by about 50.No patient harm reported.Nihon kohden clinical support (nk cas) informed the nurse that there is no settings that would cause that discrepancy and recommeded that it could possibly be the way their vitals are being mapped to their electronic medical records (emr) system.The nurse later confirmed that the issue was due to how they had the settings mapped to their emr system and once it was mapped properly issue was resolved.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.
Event or Problem Description
The nurse reported that during a surgery there was a discrepancy between the bedside monitor (bsm) and their electronic medical record (emr).The nurse reported that the discrepancy was between the saturation of peripheral oxygen (spo2) and electrocardiogram (ecg) heart rate which is off by about 50.No patient harm reported.Nihon kohden clinical support (nk cas) informed the nurse that there is no settings that would cause that discrepancy and recommeded that it could possibly be the way their vitals are being mapped to their electronic medical records (emr) system.
Additional Manufacturer Narrative
Details of complaint: the nurse reported that during a surgery, there was a discrepancy between the bedside monitor (bsm) and the electronic medical record (emr) regarding the saturation of peripheral oxygen (spo2) and electrocardiogram (ecg) heart rate, which was off by about 50.The nurse later confirmed that the issue was due to how they had the settings mapped to their emr system and once it was mapped properly, the issue was resolved.No patient harm or injury was reported.Investigation summary: nihon kohden was able to confirm the root cause of the issue was due to a user related setup error, as the settings were incorrectly mapped.Nihon kohden clinical support (nk cas) was able to assist the customer in resolving the reported issue.During a review of the history of complaints for the reported device, this was the only issue found at this facility in the past (3) three years.A significant trend that would warrant any action and/or any corrective action has not been observed.A significant trend that would suggest a design or manufacturing issue or warrant any further corrective action has not been observed.In this case, the issue was due to a user related setup error, as the settings were incorrectly mapped.Nk ts, cas, and the facility's it teams were able to work together to provide the customer with education, guidance, and assistance in resolving the issue.Trending will continue to be monitored for this device, incident issues, and causes.
Event or Problem Description
The nurse reported that during a surgery, there was a discrepancy between the bedside monitor (bsm) and the electronic medical record (emr), which was regarding the saturation of peripheral oxygen (spo2) and electrocardiogram (ecg) heart rate, which was off by about 50.No patient harm reported.

• Brand Name: BSM-1773A
• Common Device Name: BEDSIDE MONITOR, NK SPO2
• 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: 14715248
• Report Number: 8030229-2022-02913
• Device Sequence Number: 17451526
• Product Code: MHX
• UDI-Device Identifier: 04931921111956
• UDI-Public: 4931921111956
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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-1773A
• Device Catalogue Number: BSM-1773A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2015
• 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