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

Model Number	9004050
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had a clock error.No patient injury was reported.
Additional Manufacturer Narrative
Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacturing of the device.A product sample was received for evaluation.Visual and functional testing were performed.No physical damage was observed.The technician powered up the monitor and the time clock error was observed.The reported issue of clock error was duplicated.The technician replaced the real time clock (rtc) battery and factory calibration was performed to resolve the reported issue.The device operated as intended.The device passed all the functional test.The root cause of reported issue was determined to be the degradation due to prolonged use (10years).Operator of device is unknown.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BCI CAPNOCHECK PLUS
• 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: 15320407
• Report Number: 3012307300-2022-16727
• Device Sequence Number: 14819687
• Product Code: CCK
• UDI-Device Identifier: 10610586036866
• UDI-Public: 10610586036866
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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
• Device Model Number: 9004050
• Device Catalogue Number: 9004050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2010
• 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