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

Model Number	8400
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.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 unit was off per reading, re-calibrated".Patient involvement is unknown.
Additional Manufacturer Narrative
Evaluation codes: updated.Device evaluation: one device was returned for investigation.Visual inspection found no impact or corrosion damage was present and the tamper sticker was intact.Functional testing found the etco2 reading was approximately 45 mmhg @ 12 bpm.The specification at the current atmospheric pressure is 70 to 78 mmhg @ 12 bpm.Performed a hi/lo calibration and etco2 reading is still not within specification.Swapped out the co2 sensor and now getting a etco2 reading of approx.74 mmhg @ 12 bpm.The complaint was confirmed.Root cause was attributed to a faulty co2 sensor.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Replaced faulty co2 sensor.Replaced naphion tubing and absorber as preventative maintenance.Device passed functional testing after the completed repairs.

• Brand Name: BCI CAPNOCHECK II, HANDHELD CAPNOGRAPHY MONITOR
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18352105
• Report Number: 3012307300-2023-12086
• Device Sequence Number: 8425341
• Product Code: CCK
• UDI-Device Identifier: 10610586036736
• UDI-Public: (01)10610586036736(11)160126
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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: 8400D
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2016
• 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