MAUDE Adverse Event Report: ST PAUL BCI; OXIMETER

Model Number	WW1000EN
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that is non-functional, and all the lights are lit up constantly.The customer is unable to obtain a reading.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol b10010116, as a result of warning letter cms#617147.A product sample was received for evaluation.Visual inspection showed there was no physical damage on the device.During functional check, the reported complaint was verified.The returned monitor was tested with a 4086 multi-parameter simulator and passed.However, when the returned the finger probe was connected to the monitor there was no reading.A good known finger probe was used to test the monitor and worked.The customer finger probe is defective.The customer will need to purchase a new finger probe.There was no light flashing during the test.

• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12724972
• Report Number: 3012307300-2021-10472
• Device Sequence Number: 11886838
• Product Code: DQA
• UDI-Device Identifier: 30843418000016
• UDI-Public: 30843418000016
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• 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: WW1000EN
• Device Catalogue Number: WW1000EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• 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: 09/30/2021
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 10/30/2021
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2019
• 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