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

Model Number	9004051
Medical Device Problem Code	Power Problem (3010)
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 power lights were flashing.No patient injury was reported.
Additional Manufacturer Narrative
A product sample was received to perform an investigation.A visual inspection found the tamper seal was removed.No physical damage was noted on the device.Functional testing was performed.The power cord was plugged into the monitor, the monitor powered on, and the light emitting diode (led) power light started flashing.The blinking led light indicated that the battery was charging.This occurred while the external power was left applied.This information is provided to the user in the operation manual.A device history record (dhr) review was not performed because the results of the complaint investigation did not indicate a problem with the initial manufacture or prior repair of the device.The device operated as intended.The problem source was determined to be user interface.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: BCI CAPNOCHECK SLEEP 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: 15467077
• Report Number: 3012307300-2022-20143
• Device Sequence Number: 6881230
• Product Code: CCK
• UDI-Device Identifier: 10610586036873
• UDI-Public: 10610586036873
• 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): 09/22/2022

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: 9004051
• Device Catalogue Number: 9004051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• 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: 05/16/2022
• Initial Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2018
• 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