MAUDE Adverse Event Report: ST PAUL BCI; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number 3311

Device Problem Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that a smiths medical device never worked out of the package.No patient involvement.

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: 3012307300-2021-10276.The report was submitted in error., corrected data: corrected information provided in h10.

• Brand Name: BCI
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• 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: 12700747
• MDR Text Key: 278537620
• Report Number: 3012307300-2021-10276
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 15019517058253
• UDI-Public: 15019517058253
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3311
• Device Catalogue Number: 3311
• Device Lot Number: 021525-1-6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1