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

Model Number	8401
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was blank screen.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Other text: it has been determined that complaint file (b)(4) with a manufacturing report number of 3012307300-2023-02851 is not a reportable complaint.Please disregard the previous submission(s).Any additional reporting will be conducted under the applicable file.
Additional Manufacturer Narrative
Evaluation codes: updated.One device was received.Visual inspection noted the battery compartment was damaged.The monitor display is illuminated but no screen information was visible.Tried adjusting screen contrast but this did not help.The customer complaint is confirmed.A device history record (dhr) review was not performed because the device is beyond a year from its manufacture date and there was no indication of a manufacturing defect during the investigation.Service history review identified this device has not been in for service previously.Actions taken by the manufacturer; after swapping out the mainboard there was visible screen information on the display image.

• Brand Name: BCI CAPNOGRAPHY MONITOR 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: 16587610
• Report Number: 3012307300-2023-02851
• Device Sequence Number: 13878091
• Product Code: CCK
• UDI-Device Identifier: 10610586036781
• UDI-Public: 10610586036781
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/14/2023

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 Model Number: 8401
• Device Catalogue Number: 8401
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/08/2023
• 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: 03/01/2023
• Supplement Date Received by Manufacturer: 05/09/2023; 07/21/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 05/26/2023; 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2018
• 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