PRODUCT VYNTUS ONE

Additional Manufacturer Narrative

A PREVIOUS CAPA INVESTIGATION IDENTIFIED THE FOLLOWING ROOT CAUSE OF THIS EVENT: MISUSE OF THE USS AS A ¿HANDLE¿ TO CHANGE THE SUPPORT ARM POSITION INSTEAD OF USING THE PROPER HANDLE OF THE SUPPORT ARM. THIS MISUSE LOOSENS THE MECHANICAL CONNECTION BETWEEN THE USS AND THE FPV SO IT BECOMES INSUFFICIENT TO HOLD THE USS IN PLACE. AS A RESULT OF THE CAPA, THE INSTRUCTIONS FOR USE WERE UPDATED ACCORDINGLY TO ENSURE THAT FUTURE INCIDENTS ARE AVOIDED. THE AFFECTED SENSOR WAS NOT SENT BACK FOR INVESTIGATION. A PICTURE OF THE USS REVEALED THAT THE SENSOR LOOKS WORN, WHICH COULD BE THE REASON WHY THE USS SENSOR COULD COME OFF THE ARM EVEN MORE EASILY. NEVERTHELESS, AS NEW INCIDENTS OF THIS TYPE WERE REPORTED BY CUSTOMERS A NEW CAPA WAS RAISED TO PREVENT FURTHER OCCURRENCES. THIS INCIDENT IS CLASSIFIED WITH A RISK LEVEL OF MEDIUM AND IS AN ACCEPTABLE PATIENT RISK.

Description of Event or Problem

ON 10/24/2024 IT WAS REPORTED TO VYAIRE THAT WHEN THE PATIENT PULLED ON THE USS SENSOR TO READJUST THE POSITIONING OF THE ARM THE USS SENSOR FELL OUT OF HOUSING. THIS RESULTED IN THE USS SENSOR HITTING THE PATIENT'S FACE AND CAUSING A CUT ON THE LIP. IT WAS REQUIRED TO APPLY A PLASTER/TISSUE TO THE INJURED LIP TO STOP THE BLEEDING. THIS INCIDENT OCCURRED TWICE IN THE SAME HOSPITAL, BUT WITH A DIFFERENT PATIENT ON A DIFFERENT DEVICE AND WITH ANOTHER HEALTHCARE PROFESSIONAL. THE OTHER INCIDENT WILL BE REPORTED IN A SECOND REPORT WITH OUR REFERENCE NUMBER (B)(4).