MAUDE Adverse Event Report: ST PAUL BCI; MONITORING

Model Number 3301A1

Device Problem Circuit Failure (1089)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2021

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 268646564
• Report Number: 3012307300-2021-08947
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2021
• 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: 08/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1