MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BCI CAPNOGRAPHY MONITOR, CAPNOCHECK II, MODEL 8400; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	8400
Medical Device Problem Codes	Failure to Sense (1559); Calibration Problem (2890)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.H3: device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the co2 sensor failed during high calibration.There was unknown patient involvement and unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
D9.Date returned to mfg: 27-jun-2024.H6.Investigation codes: updated.Investigation summary: the affected device was returned for evaluation.Visual inspection performed.No impact or corrosion damage present.High/low calibration and flow rate check performed.At the end of the calibration check, the co2 sensor error message was displayed.Getting approx.0 ml/min co2 pump flow rate.On closer inspection, the input barbed fitting was damaged where the naphion tubing is connected to.This caused a leak in the pneumatic circuit.The customer's complaint was confirmed, and the root cause was the damaged input barbed fitting.Replacing the input fitting fixed the problem.The device passed all functional testing after repair.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: BCI CAPNOGRAPHY MONITOR, CAPNOCHECK II, MODEL 8400
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19510962
• Report Number: 3012307300-2024-04824
• Device Sequence Number: 17035633
• Product Code: CCK
• UDI-Device Identifier: 10610586036354
• UDI-Public: (01)10610586036354(11)190114
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K991086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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: Other
• Device Model Number: 8400
• Device Catalogue Number: 8400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown