MAUDE Adverse Event Report: ST PAUL MONITORING BCI; OXIMETER

Catalog Number 1303

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event 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.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(6), as a result of warning letter cms# (b)(6).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 was returned to the supplier.

• Brand Name: MONITORING BCI
• Type of Device: 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: 12337337
• MDR Text Key: 267092520
• Report Number: 3012307300-2021-08566
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2023
• Device Catalogue Number: 1303
• Device Lot Number: 1925-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1