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

Catalog Number	8400
Medical Device Problem Codes	Crack (1135); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: one device was returned for investigation.Visual inspection found the case window was cracked.On closer inspection, it was noticed that the case window has sustained damage consistent with being subjected to impact force.However, could not verify the inaccuracy issue.The co2 and spo2 functions are operating within factory specifications.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.Replaced damaged case window.Replaced keypad as part of the window replacement.Replaced naphion tubing as a preventative measure.
Event or Problem Description
It was reported that the device screen was cracked and readings were inaccurate.It is unknown if there was physical damage.Patient involvement is unknown.No harm has been reported.

• Brand Name: BCI HANDHELD CAPNOCHECK II, PATIENT 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: 19313589
• Report Number: 3012307300-2024-03685
• Device Sequence Number: 16913209
• Product Code: CCK
• UDI-Device Identifier: 10610586036354
• UDI-Public: (01)10610586036354(11)140506
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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 Catalogue Number: 8400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2014
• 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