MAUDE Adverse Event Report: ST PAUL BCI INTL., INC.; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	9004051
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device wold calibrate correctly with 10% co2, reading in the twenties when hooked up to a patient.Confirmed the event was not due to the patient, by using a secondary (working) device.Not able to do a factory calibration, would like to send it in.No patient injury was reported.
Additional Manufacturer Narrative
Other, one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The pump was found to be defective, but the problem source is unknown.A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the initial manufacture of the device.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.There was no physical damage on the device.The technician performed flow rate test, carbon dioxide (c02) test, swap parts, and battery life test the reported complaint was not duplicated after calibrate the c02 on the returned 9004051 monitor and the device was able to calibrate and read c02 properly.However, the flow rate failed with low reading at 102 milliliter ml/min (spec: 150 +/-20 ml/min.) the low reading would cause intermittent issues describe by the customer.Due to the process of elimination, the c02 pump was defective and had cause the monitor to have a low flow rate.The pump was swapped with another c02 pump and the flow rate increase to 154 ml/min.The technician checked c02 10 percent gas at 61 millimetre of mercury (mmhg) and performed low calibration at 73 mmhg.The technician performed high/low c02 calibration and read at 73 mmhg.The current barometric pressure was measured at 731.The main battery failed the battery life test.The root cause of the reported issue was found to be a defective c02 pump.The technician replaced c02 pump and main battery.

• Brand Name: BCI INTL., INC.
• 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; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; dock 5; minneapolis, MN 55442
• MDR Report Key: 13950161
• Report Number: 3012307300-2022-05502
• Device Sequence Number: 4368090
• Product Code: CCK
• UDI-Device Identifier: 10610586036873
• UDI-Public: 10610586036873
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup,Followup
• Report Date (Section B): 04/25/2023

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: 9004051
• Device Catalogue Number: 9004051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 04/06/2022; 03/06/2023
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 05/05/2022; 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2014
• 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