MAUDE Adverse Event Report: ICU MEDICAL, INC. BCI CAPNOCHECK LL HANDHELD CAPNOGRAPH; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Catalog Number	8401
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Reason device not evaluated by mfg: other; device was 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 monitoring device had an error with the co2 sensor.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
D3 - mfg establishment name and address: corrected.H3 and h6 codes - updated.The suspected device was returned for evaluation.No discrepancies related to the complaint were found during visual inspection.During power on test, sensor error message is not displayed.However, during the hi/low calibration, the sensor is not detecting the calibration gas and high co2 unstable error message displayed at the end.The co2 sensor was replaced to correct the issue.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.The device passed all functional tests after the repair.It is not anticipated that the reported malfunction would result in interruption of therapy or serious injury.

• Brand Name: BCI CAPNOCHECK LL HANDHELD CAPNOGRAPH
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21069284
• Report Number: 3012307300-2025-00209
• Device Sequence Number: 18245056
• Product Code: CCK
• UDI-Device Identifier: 10610586036781
• UDI-Public: (01)10610586036781(11)131218
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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 Catalogue Number: 8401
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2013
• 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