MAUDE Adverse Event Report: ST PAUL BCI CAPNOCHECKPLUS SLEEP CARBON DIOXIDE DETECTOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	9004002
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
First time in for service after 11 years in the field and the reported problem is a perception from check sum version loaded during the power-up process and not an error.The dhr review is not applicable or relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.The device was returned for evaluation.Visual and functional testing were performed.Visual inspection found that the unit was dirty.The reported complaint was duplicated the monitor was turned on and there was no error e484.The e484 is not an error it is the sum check of the 1.12 software.So, the e484 is what you should see when the monitor is power on.However, charged the returned monitor overnight; then pressed on/off button and the monitor wouldn?t power on.A visual inspection of the internal area the monitor was conducted by removing the main battery and leaving the ad/dc power adapter plugged in, then pressing the on/off key and the monitor powered up.The main battery is defective and will need to be replaced.This is the first time that the monitor was returned for service.The root cause of the reported issue was found to be that the main battery was defective.The rtc and main battery were replaced.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the device is presenting with an error e484.No patient injury was reported.

• Brand Name: BCI CAPNOCHECKPLUS SLEEP CARBON DIOXIDE DETECTOR
• 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): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15397992
• Report Number: 3012307300-2022-18593
• Device Sequence Number: 6179438
• Product Code: CCK
• UDI-Device Identifier: 10610586036835
• UDI-Public: 10610586036835
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2022

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: 9004002
• Device Catalogue Number: 9004002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 09/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2008
• 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