MAUDE Adverse Event Report: ST PAUL BCI; CAPNOCHECK SLEEP CAPNOGRAPH/OXIMETER

Model Number	9004050
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the co2 reading really high of 60.No patient injury reported.
Additional Manufacturer Narrative
During the investigation the monitor came in for? co2 reading really high? the customers comments are verified.The flowrate was checked, and it read 134 ml/min (spec 150+/-+20 ml/min).Applied 10% gas and got 100 and the barometric pressure for the day is 74.0 mmhg so it was way out of spec, then a lo cal was performed and got 100, then a hi/lo calibration was performed and read 72.0 mmhg (spec 74 mmhg+/-3) which is in spec for the day's pressure.The customer should make sure they are using the bci cal gas, the kit # is 8217 if you need to order.If the customer is using the wrong gas, they can get number like this and will happen again due to this monitor is supposed to have a hi/lo calibration every 6 months.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.

• Brand Name: BCI
• Common Device Name: CAPNOCHECK SLEEP CAPNOGRAPH/OXIMETER
• 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: 15401649
• Report Number: 3012307300-2022-18639
• Device Sequence Number: 6124028
• Product Code: CCK
• UDI-Device Identifier: 10610586036866
• UDI-Public: 10610586036866
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2022

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: 9004050
• Device Catalogue Number: 9004050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown