MAUDE Adverse Event Report: ST PAUL BCI CAPNOCHECK SLEEP CAPNOGRAPH/OXIMETER; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	9004050
Medical Device Problem Codes	Device Alarm System (1012); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was an occlusion error and the pumps were loud.No patient injury was reported.
Additional Manufacturer Narrative
A dhr review was not conducted, based upon review of the information provided by the customer, as it does not indicate a problem with the initial manufacture or prior repair of the device.The product was received for evaluation.Visual and functional testing were performed.The physical condition on the product was fair, had a dirty case, small scratches and dents.The reported complaint was verified after performed flow rate on the returned monitor with no flow.The root cause of the reported issue was found to be the tubing by top case handle ridge against carbon dioxide (co2) pump casing and malfunctioning co2 pump due to wear of age.The technician replaced the co2 pump, tubing and restrictor.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BCI CAPNOCHECK SLEEP CAPNOGRAPH/OXIMETER
• 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: 15327553
• Report Number: 3012307300-2022-17011
• Device Sequence Number: 20168414
• Product Code: CCK
• UDI-Device Identifier: 10610586036866
• UDI-Public: 10610586036866
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2005
• 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