MAUDE Adverse Event Report: ST PAUL BCI; OXIMETER

Model Number 3301A1

Device Problem Failure to Power Up (1476)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2021

Event Type  malfunction  

Event Description

It was reported that a smiths medical oximeter won't turn on.No adverse patient effects were reported.

Manufacturer Narrative

Corrected data: date of event updated, not used on patient, and no adverse effects.

Manufacturer Narrative

Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Internal inspection of the inside of the device, found power pin j9 with no solder.The loose pin j9 would cause an intermittently power issues with the device.Solder was added to pin j9.The device was powered on and the intermittent power issue was resolved.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-10493.The report was submitted in error.

• Brand Name: 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12725733
• MDR Text Key: 279260465
• Report Number: 3012307300-2021-10493
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 30843418000849
• UDI-Public: 30843418000849
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3301A1
• Device Catalogue Number: 3301A1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1