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

Catalog Number 8401

Device Problem Unable to Obtain Readings (1516)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

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 Description

It was reported that the device would not register a reading.Patient involvement unknown.

Manufacturer Narrative

H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was received.Per visual inspection, co2 pump was dislodged and one of the screws that held the valve was missing.Battery compartment cracked.Per functional testing, when powering up the monitor, there was no co2 pump reading and no flowrate reading.The complaint was confirmed.The root cause was a defective co2 pump and valve likely from impact sustained by the monitor during use and handling causing damage to the battery compartment however this could not be confirmed.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 co2 pump and valve.Replaced nafion tube for preventative maintenance (pm).Glued the battery compartment back together and tightened all the screws and nuts.The monitor passed all functional tests.

• Brand Name: BCI CAPNOGRAPHY MONITOR CAPNOCHECK II
• Type of Device: 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: 17646390
• MDR Text Key: 322254392
• Report Number: 3012307300-2023-08477
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036781
• UDI-Public: 10610586036781
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8401
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1