MAUDE Adverse Event Report: ST PAUL BCI; OXIMETER

Model Number	1303
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
Event or Problem Description
Information received a smiths medicsl patient monitoring|bci oximeter disposables reported sensors show defects after 1 to 2 days in use.Customer stated they do not dissipate, provide incorrect measure values and the cables of new sensors are already exposed as missing cable covers.
Additional Manufacturer Narrative
Other text: device was supplied.Further investigation will be done by the supplier.No further information is available.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.The device sometimes had no readings, wire interruption, adhesive tape was thin and stretched the root cause of the reported issue was found to be a user interface problem.Device will be returned to the supplier.

• 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: 12294086
• Report Number: 3012307300-2021-08213
• Device Sequence Number: 4137215
• Product Code: DQA
• UDI-Device Identifier: 15019517042511
• UDI-Public: 15019517042511
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K920082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2023

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 Expiration Date: 12/02/2023
• Device Model Number: 1303
• Device Catalogue Number: 1303
• Device Lot Number: 1952-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 09/22/2021; 04/27/2023
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 10/22/2021; 05/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown