MAUDE Adverse Event Report: ST PAUL PORTEX; AIRWAY PRESSURE MONITOR

Model Number	008201
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were ink stains on the devices.
Additional Manufacturer Narrative
Other, other text: additional information added to h6 and h10.This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.Based on pictures provided in complaint investigation, after images review ink stains inside tube can be observed.The root cause of the reported issue was found to be operator mishandling using production equipment.Actions were taken to mitigate the reported issue: a notification awareness to operators were issued in order to notify all personnel about issue reported with ink stains on manometer surface.

• Brand Name: PORTEX
• Common Device Name: AIRWAY PRESSURE MONITOR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12277282
• Report Number: 3012307300-2021-08066
• Device Sequence Number: 11541283
• Product Code: CAP
• UDI-Device Identifier: 10351688426352
• UDI-Public: 10351688426352
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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: 008201
• Device Lot Number: 4079322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2021
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown