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

Model Number 8400

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2023

Event Type  malfunction  

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 Description

It was reported that "the unit was off per reading, re-calibrated".Patient involvement is unknown.

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
• Type of Device: 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
• MDR Text Key: 331074103
• Report Number: 3012307300-2023-12086
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036736
• UDI-Public: (01)10610586036736(11)160126
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 01/15/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1