MAUDE Adverse Event Report: OAKDALE BCI CAPNOGRAPHY MONITOR, CAPNOCHECK II, MODEL 8400; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Catalog Number	8400D
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that the device gave a "co2 pressure unstable" message.Patient involvement is unknown.
Additional Manufacturer Narrative
A1, b5 and h6.Health effects codes, updated.
Event or Problem Description
Additional information received.This was discovered during preventative maintenance.No patient involved.
Additional Manufacturer Narrative
Other, other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was received.Per visual inspection, the screw that holds the valve to the battery compartment and tubing were loose and contaminated.The fan was loose, and the co2 pump was dislodged.Per functional testing, after powering up the device, the flow rate reading was out of specification.Internal inspection the device, found nafion tube and the absorber contaminated.The complaint was confirmed.The root cause was contaminated internal co2 tubing from moisture accumulation from usage and loose screws and connection from physical impact 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.Replaced contaminated tube.Replaced nafion tube and absorber for preventative maintenance (pm).Pushed the co2 pump back in its spot.Applied hot melt to the fan and tighten all screws.Replaced the restrictor to adjust the flow rate.The device has passed all functional tests.

• Brand Name: BCI CAPNOGRAPHY MONITOR, CAPNOCHECK II, MODEL 8400
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17829764
• Report Number: 3012307300-2023-09285
• Device Sequence Number: 14565413
• Product Code: CCK
• UDI-Device Identifier: 10610586036736
• UDI-Public: 10610586036736
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 11/17/2023

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: 8400D
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/13/2023
• 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: 09/07/2023
• Supplement Date Received by Manufacturer: 09/28/2023; 10/30/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 10/25/2023; 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2012
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown