MAUDE Adverse Event Report: ST PAUL BCI; CAPNOGRAPHY MONITOR

Model Number 8401

Device Problem Component Missing (2306)

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

Event Date 08/05/2021

Event Type  malfunction  

Event Description

Information was received by smiths medical that a box only had the charger and did not contain the actual monitor.No patient harm.

Manufacturer Narrative

Other text: one photo was provided for investigation.The photo only showed the 8404 battery charger with no other accessories, but does not show them inside the shipping box.After review of the manufacturing device history records concluded that this was built to specification and had passed all functional tests.This monitor is built as a pick to order item (pto), meaning the noted 8404 charger would have been picked separately and added to the monitor inside an empty shipping box of the monitor which would have caught the attention of the shipping personnel, had the monitor been missing from manufacturing.It came to our conclusion that the distributor incorrectly shipped item 8404 to the customer instead of the 8401 monitor instead.

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: 3012307300-2021-09199.The report was submitted in error.

• Brand Name: BCI
• Type of Device: CAPNOGRAPHY MONITOR
• 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; chrp bldg 4a room 150a; minneapolis, MN 55442
• MDR Report Key: 12426644
• MDR Text Key: 270100452
• Report Number: 3012307300-2021-09199
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036781
• UDI-Public: 10610586036781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 09/05/2021
• Supplement Dates Manufacturer Received: 10/20/2021; 05/02/2023
• Supplement Dates FDA Received: 11/17/2021; 05/07/2023
• 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