MAUDE Adverse Event Report: NULL PORTEX GENERAL ANESTHESIA PREMIUM PLUS MASKS; MASK, OXYGEN

Model Number 15255

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Date 10/14/2021

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, a tear was found in the product, from where leakage of air was observed.

Manufacturer Narrative

One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Photos were sent to the supplier for further investigation.Dhr review will be done by the supplier.

• Brand Name: PORTEX GENERAL ANESTHESIA PREMIUM PLUS MASKS
• Type of Device: MASK, OXYGEN
• Manufacturer (Section G): NULL
• MDR Report Key: 12804925
• MDR Text Key: 280705041
• Report Number: 3012307300-2021-11143
• Device Sequence Number: 1
• Product Code: BYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15255
• Device Catalogue Number: 15255
• Device Lot Number: 210607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1