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

Catalog Number	8401
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device had low o2 unstable.No additional information.
Additional Manufacturer Narrative
B3: date of event is unknown.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 information becomes available.
Event or Problem Description
Correction: there was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
A1-a6, b5: corrected.H6: investigation codes: updated.Investigation summary: the affected device was returned for evaluation.The customer reported issue was low co2 unstable.The customer reported issue was not able to be confirmed through calibration.The cause of the reported issue was unable to be determined or verified through evidence and test methods available.No action required - monitor is operating within factory specifications.Device passed all functional and delivery tests performed after repair activities were completed.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
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21734554
• Report Number: 3012307300-2025-03485
• Device Sequence Number: 17145712
• Product Code: CCK
• UDI-Device Identifier: 10610586036781
• UDI-Public: (01)10610586036781(11)120207
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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: 03/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2012
• 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