MAUDE Adverse Event Report: ST PAUL BCI; CAPNOGRAPH

Model Number 8401

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical capnograph had a bad screen.

Manufacturer Narrative

Other, other text: b5: additional info received via email 12-nov-2021:date of event is unknown, there was no patient involvement, the event occurred during testing.H6: event problem and evaluation codes: updated after device evaluation.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the speaker was found loose and the c02 pump was shifted.The customer stated problem was duplicated.There was an impact of the device found.Replace lcd screen, add battery cover.The cause of the reported problem was traced to the user manipulation of the device.The dhr review is not relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.

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: 3012307300-2021-09161.The report was submitted in error.

• Brand Name: BCI
• Type of Device: CAPNOGRAPH
• 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: 12425894
• MDR Text Key: 270084942
• Report Number: 3012307300-2021-09161
• 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: 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: 09/03/2021
• 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?: Device Returned to Manufacturer
• 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: 06/14/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1