MAUDE Adverse Event Report: ST PAUL BCI; OXIMETER

Model Number	6004001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One unit was returned for investigation.The reported complaint was verified after a leak test was performed.It was found that the valve was leaking which causes the intermittent reading.Root cause analysis is unknown, no dhr review done.
Event or Problem Description
It was reported that the device takes blood pressure intermittently.
Additional Manufacturer Narrative
Other text: one device was returned for evaluation with no outward issues found upon visual inspection.Physical inspection, including leak testing was done where it was found that the niibp valve was leaking.It was found that the issue was due to the old age of the device.Dhr review was not done as the results of the investigation do not point to initial manufacturing of the device.No other faults were found.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-09697.The report was submitted in error.

• Brand Name: BCI
• Common Device Name: OXIMETER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13025851
• Report Number: 3012307300-2021-09697
• Device Sequence Number: 19274042
• Product Code: DQA
• UDI-Device Identifier: 10610586036583
• UDI-Public: 10610586036583
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K031742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2023

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: 6004001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 11/01/2021; 05/02/2023
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 12/20/2021; 05/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown