VENTURI MASK KIT ADULT

Additional Manufacturer Narrative

THE LAST THREE (3) PRODUCT MONITORING REVIEWS (PMRS) WERE REVIEWED AND NONE OF THE AFFECTED PRODUCT CODES HAVE ILLUSTRATED ANY TRENDS FOR PRODUCT CATEGORY OR ANY MALFUNCTION OR ANY HARM. MORE SPECIFICALLY, THERE WERE NO TRENDS OBSERVED FOR THE OXYGEN MASKS. COMPLAINTS SPANNING FROM OCTOBER 27, 2014 THROUGH OCTOBER 27, 2016 (2 YEARS) WERE REVIEWED AS IT RELATED TO REPORTS OF NOZZLE ISSUES. A TOTAL OF THREE (3) COMPLAINTS WERE REPORTED FROM A SINGLE COMPLAINANT. NO TRENDS WERE OBSERVED. NO HARMS REPORTED. IN ALL CASES, THE PRODUCT WAS DISCONTINUED AND REPLACED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON JANUARY 20, 2017.

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO PATIENT HARM WAS REPORTED. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT NOT PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON OCTOBER 28, 2016. (B)(4).

Description of Event or Problem

COMPLAINT REPORTING THAT "THE CONNECTOR PRESENTED DIAMETER TOO SMALL CAUSING TURBULENCE AND WHISTLE WHEN ADMINISTERING OXYGEN. THE PROBLEM IS THAT THIS MASK PROVIDES DIFFERENT RANGES OF ADJUSTMENT, WHICH CAN NOT BE USED, SINCE THE WHISTLE BEGINS. OF THE SIX (6) LEVELS CAN BE USED ONLY TWO (2). NORMALLY THIS MASK SHOULD BE ADJUSTED TO 50%; BUT DUE TO THE PROBLEM, IT IS USED TO 28% OR SHOULD BE MANIPULATED." THE REPORTED ISSUE WAS NOTED IMMEDIATELY AND THE DEVICE WAS REMOVED AND DISCONTINUED. NO FURTHER INFORMATION WAS PROVIDED.