MAUDE Adverse Event Report: ST PAUL BCI CAPNOGRAPHY CAPNOCHECK II; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Catalog Number	8400
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Calibrate (2440)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device's carbon monoxide (c02) readings are not accurate and the unit will not calibrate.Patient involvement is unknown.
Additional Manufacturer Narrative
Other, other text: 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 or Problem Description
Additional information received via email."the request was cancelled with reference ps ref 6919712.No further details provided".
Additional Manufacturer Narrative
One device was received.Per visual inspection, battery compartment cracked, no flowrate reading.Loose screws and speaker inside, screw and nut were missing.Co2 pump was dislodged.The battery door foam was torn half off and nafion tube was contaminated.Per functional testing, the monitor would not power on due to the cracked battery compartment.Held battery compartment closed and monitor powered up, but no reading on flow rate?.The complaint was confirmed.The root cause was disconnected co2 tubing as a result of physical impact sustained by the monitor during use and handling.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.Reassembled disconnected parts.Replaced the nafion tube for preventative maintenance (pm).Replaced restrictor to adjust the flowrate and replaced battery door foam.Device passed all functional and delivery tests.

• Brand Name: BCI CAPNOGRAPHY CAPNOCHECK II
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17471189
• Report Number: 3012307300-2023-07848
• Device Sequence Number: 19465692
• Product Code: CCK
• UDI-Device Identifier: 10610586036354
• UDI-Public: 10610586036354
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K991086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 8400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2016
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown