MAUDE Adverse Event Report: ST PAUL BCI SPECTRO2 10 PULSE OXIMETER

Model Number	WW1000A1EN
Medical Device Problem Codes	Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a trail carried out following reports of erratic reading, 3 main issues were: the size of the ear probe was too big and proved difficult to position properly.The readings were very erratic ear and finger reading at least 2 percent different, tried new pleth to no avail.Several devices in the community team same issue.The readings did not marry up with those taken using the ward high dependency monitor ear pleths, also blood gas monitor tested against.The second model we trialed had more stable readings.No patient injury was reported.
Additional Manufacturer Narrative
Manufacturing device history record review was not performed because the defective ear probe is not evaluated or testing during the manufacturing process.Manufacture records are retained by the supplier at their manufacturing site.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found device is in good conditions.No damages or defects.Functional testing found both values are valid, no difference and stable readings as expected.The root cause of the issue could not be determined.A non-conforming event has been elevated on a non-conforming report (ncr).This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BCI SPECTRO2 10 PULSE OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15362964
• Report Number: 3012307300-2022-17968
• Device Sequence Number: 20571987
• Product Code: DQA
• UDI-Device Identifier: 30843418000283
• UDI-Public: 30843418000283
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2022

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: WW1000A1EN
• Device Catalogue Number: WW1000A1EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2020
• 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