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

Model Number	9004000
Medical Device Problem Code	Failure to Power Up (1476)
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 rejected the power cord when plugged into the unit.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (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.A product sample was received for evaluation.Visual and functional testing were performed.No physical damage observed.The device was power on, the battery life was tested and charged circuitry.The reported issue was not duplicated.The root cause of the reported issue was not confirmed; however, other issues were found.The main battery would not hold charge.The technician replaced main battery.No product information has been provided to date.(b)(4).

• Brand Name: CAPNOCHECK PLUS - CAPNOGRAPH
• 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; pediatrics; minneapolis, MN 55442
• MDR Report Key: 15334399
• Report Number: 3012307300-2022-17188
• Device Sequence Number: 12485096
• Product Code: CCK
• UDI-Device Identifier: 10610586036811
• UDI-Public: 10610586036811
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/01/2022

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: 9004000
• Device Catalogue Number: 9004000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• 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: 05/24/2022
• Initial Report FDA Received Date: 09/01/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown