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

Model Number 9004051

Device Problem Erratic or Intermittent Display (1182)

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

Event Type  malfunction  

Manufacturer Narrative

A product sample was received for evaluation.Visual and functional testing were performed.The monitor was powered up and 10% gas was applied and it read 70 mmhg, performed a hi/lo calibration and the reading came in at 74 mmhg which is right on for the day, customer to perform a hi/lo calibration every 6 months like instructed in the manual.The flowrate rate was checked and it read 92 ml/min which could also contribute to erratic readings so the sleep pump was replaced.The failure resulted from co2 bench drifted out of calibration due malfunctioning co2 pump no longer drawing adequate airflow through the pneumatics.This monitor was last serviced about 1 year ago where the co2 pump was replaced to meet specification.Further device history review (dhr) 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.The complaint was confirmed.The root cause of the reported issue was found to be device out of calibration and defective pump.The device was calibrated and the sleep pump was replaced.Operator of device is unknown.Initial reported also sent report to fda is unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the device had erratic readings.No patient injury was reported.

• Brand Name: CAPNOCHECK SLEEP CAPNOGRAPH/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: 15422572
• MDR Text Key: 305892234
• Report Number: 3012307300-2022-19199
• 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
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9004051
• Device Catalogue Number: 9004051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1