MAUDE Adverse Event Report: ST PAUL BCI SPECTRO2 20 PULSE OXIMETER OPTIONAL ACCESSORIE; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	WW3311E
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cable did not meter correctly anymore.No patient injury was reported.
Additional Manufacturer Narrative
The device history record (dhr) review is not applicable due to the product is distributed purchased finished good and not produced by manufacturer.The device was received for evaluation.Visual and functional testing were performed.Visual inspection found the device was dirty and warn out.The reported complaint could not be verified after testing using the returned extension cable on a good known test probe connected to a monitor and there was reading detection.The extension cord was then tested with a multi-parameter simulator and the reading was consistent.During testing the probe was manipulated at the base and didn't fail.Performed continuity test on the extension cable and passed.The root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BCI SPECTRO2 20 PULSE OXIMETER OPTIONAL ACCESSORIE
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• 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: 15320515
• Report Number: 3012307300-2022-16741
• Device Sequence Number: 12062883
• Product Code: CCK
• UDI-Device Identifier: 15019517058253
• UDI-Public: 15019517058253
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K970209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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: Other
• Device Model Number: WW3311E
• Device Catalogue Number: 3311
• Device Lot Number: 019675-1-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 08/30/2022
• 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