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

Model Number 9004051

Device Problem Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the power lights were flashing.No patient injury was reported.

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
• Type of Device: 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
• MDR Text Key: 302192589
• Report Number: 3012307300-2022-20143
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036873
• UDI-Public: 10610586036873
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1