MAUDE Adverse Event Report: ST PAUL BCI; MONITORING

Model Number	3301A1
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical patient monitoring|bci oximeter handheld - 3301 needs a main new board, according to technician.Unknown if patient involvement occurred.
Additional Manufacturer Narrative
Other, other text: one device was returned for investigation.Upon visual inspection, the reported complaint was confirmed and duplicated.After replacing the main board the device was able to to pass a simulation test.
Additional 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: 3012307300-2021-08947.The report was submitted in error.

• Brand Name: BCI
• Common Device Name: MONITORING
• 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: 12381387
• Report Number: 3012307300-2021-08947
• Device Sequence Number: 11724545
• Product Code: DQA
• UDI-Device Identifier: 30843418000849
• UDI-Public: 30843418000849
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K943404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2023

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 Model Number: 3301A1
• Device Catalogue Number: 3301A1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 10/06/2021; 05/02/2023
• Initial Report FDA Received Date: 08/29/2021
• Supplement Report FDA Received Date: 11/03/2021; 05/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2012
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown