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 Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device has high co2 sensor error alarm.The event occurred during preventive maintenance.There was no patient involvement, and no harm/adverse event was reported.
Additional Manufacturer Narrative
D9 - date returned to manufacturing-7/18/2024.One device was received for evaluation.Functional testing was performed and did not duplicate the customer's problem.No visual testing was performed.A root cause could not be determined as there was no problem found.Monitor will have factory calibration and high/low calibration performed as part of functional testing.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: 19511089
• Report Number: 3012307300-2024-04825
• Device Sequence Number: 19684296
• Product Code: CCK
• UDI-Device Identifier: 10610586036354
• UDI-Public: (01)10610586036354(11)190220
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 08/05/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2019
• 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