MAUDE Adverse Event Report: ST PAUL HANDHELD CAPNOGRAPH CAPNOCHECK II; OXIMETER

Model Number 8400

Device Problem Output Problem (3005)

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

Event Type  malfunction  

Event Description

It was reported that the device was presenting inaccurate results.No patient injury was reported.

Manufacturer Narrative

Operator of device: no information has been provided to date.Initial reporter also sent report to fda is unknown.No information has been provided to date.Dhr review was not performed, as the results of the complaint investigation do 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.The root cause of the reported issue was determined to be the failure of co2 bench component that no longer holds calibration.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).

• Brand Name: HANDHELD CAPNOGRAPH CAPNOCHECK II
• Type of Device: OXIMETER
• 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: 15409640
• MDR Text Key: 305818153
• Report Number: 3012307300-2022-18863
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10610586036354
• UDI-Public: 10610586036354
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8400
• Device Catalogue Number: 8400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1