THE VEST APX SYSTEM

Description of Event or Problem

IT WAS REPORTED A PATIENT'S GASTROSTOMY TUBE (G-TUBE) BECAME DISLODGED AFTER USING THE VEST APX SYSTEM AND THE PATIENT REQUIRED HOSPITALIZATION. PATIENT PERFORMED THERAPY USING THE DEVICE AND, APPROXIMATELY THREE HOURS LATER, THE G-TUBE POPPED OUT. THE PATIENT REQUIRED HOSPITALIZATION FOR REINSERTION OF THE TUBE. THE CUSTOMER REPORTED THEY HAVE NOT BEEN COMPLETING THE THERAPY SINCE THE EVENT DUE TO BEING APPREHENSIVE ABOUT RESTARTING. IT WAS NOTED THAT FOAM PADDING IS USED AT THE G-TUBE SITE, HOWEVER THE CUSTOMER EXPRESSED UNCERTAINTY ABOUT WHETHER THE CURRENT FOAM IS BEING USED CORRECTLY AND REQUESTED ADDITIONAL SUPPLIES TO MODIFY IT FOR PROTECTION. THE PATIENT¿S RESPIRATORY STATUS IS CURRENTLY STABLE, AND THE MEDICAL TEAM WAS TO BE CONSULTED FOR FURTHER DIRECTION. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION, AND THE DEVICE IS NOT BEING RETURNED AS IT REMAINS WITH THE PATIENT FOR CONTINUED USE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

THE DEVICE IS NOT BEING RETURNED THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. ADDITIONALLY, PER THE INSTRUCTIONS FOR USE (IFU), ¿THE CONTOUR FOAM (PART NUMBER 300177000) IS AN OPTIONAL ACCESSORY. THE FOAM HELPS TO PROVIDE COMFORT FOR THE PATIENT WHO HAS A HICKMAN CATHETER, PORTACATH, AND/OR G-TUBE. THE INSTRUCTION FOR USE OUTLINES THE APPROPRIATE MODIFICATIONS AND PLACEMENT OF FOAM FOR THE PATIENT¿S APPLICABLE INSERTED DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.