MAUDE Adverse Event Report: ST PAUL BCI MONITOR; CCK

Model Number	9004051
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that no wave and not responding to breaths, giving intermittent issues.No adverse patient effects were reported.
Additional Manufacturer Narrative
Other, other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Malfunctioning co2 pump mechanism was unable to draw adequate airflow through the pneumatics.A good known co2 pump was swapped to bring the airflow to within range.However, the tamper seal was broken and the main board was dislodged from the back panel referring to user tampering and/or drop damage.Therefore, unable to determine what caused the co2 pump failed.Further dhr review is not relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-10830.The report was submitted in error.

• Brand Name: BCI MONITOR
• Common Device Name: CCK
• 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; minneapolis, MN 55442
• MDR Report Key: 12763904
• Report Number: 3012307300-2021-10830
• Device Sequence Number: 19915036
• Product Code: CCK
• UDI-Device Identifier: 10610586036873
• UDI-Public: 10610586036873
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2023

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: 10/18/2021
• 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: 10/12/2021
• Supplement Date Received by Manufacturer: 12/13/2021; 05/02/2023
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 01/11/2022; 05/07/2023
• 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