MAUDE Adverse Event Report: ST PAUL PORTEX HYPERINFLATION RESUSCITATION MANOMETERS; MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR AL

Model Number	008201
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: e4: customer reported to fda is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.Pictures were received in complaint investigation, during review of the images ink stains inside tube were 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.
Event or Problem Description
It was reported that there were ink stains on the surface.No patient injury was reported.

• Brand Name: PORTEX HYPERINFLATION RESUSCITATION MANOMETERS
• Common Device Name: MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR AL
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16857620
• Report Number: 3012307300-2023-04907
• Device Sequence Number: 16985597
• 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: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2023

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 Expiration Date: 04/09/2024
• Device Model Number: 008201
• Device Catalogue Number: 008201
• Device Lot Number: 4132331
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2021
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• 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