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

Model Number	8400D
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a smiths medical capnograph keeps rebooting and screen damage.No adverse patient effects were reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.The device built before tamper seal was implemented.The device lens is cracked.The device was tested and the power on off unit, visual inspection, and swap parts and the reported issue was duplicated.The reported complaint was verified after power on the returned monitor and the device would try to power up but keeps on flashing ?memory check error.? due to the process of elimination, the main board was swapped with a good known board and the device powered up correctly.The main board failure was from impact sustained by the monitor during use and handling.The main board and crack lens were replaced.The c02 pump was found shifted.Due to all the evidence this is impact to the monitor.The root cause was due to user interface.

• Brand Name: BCI
• Common Device Name: 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12808345
• Report Number: 3012307300-2021-11222
• Device Sequence Number: 4757044
• Product Code: CCK
• UDI-Device Identifier: 10610586036736
• UDI-Public: 10610586036736
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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: 8400D
• Device Catalogue Number: 1-847-437-5500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 11/14/2021
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown