CLARIUS ULTRASOUND SCANNER

Additional Manufacturer Narrative

THE DEVICE HARDWARE WAS NOT PHYSICALLY RETURNED TO CLARIUS. HOWEVER, THE DEVICE SOFTWARE (CLARIUS APP) WAS EVALUATED BY CLARIUS CUSTOMER SUPPORT TEAM. THE ISSUE WAS SUCCESSFULLY RESOLVED BY UNINSTALLING AND THEN REINSTALLING THE APPLICATION. THE REPORT WAS RE-SUBMITTED ON OCTOBER 17TH 2024 DUE TO THE FOLLOWING REPORT FAILURE NOTICE: "THE REPORT IDENTIFIER YEAR IS NOT VALID".

Description of Event or Problem

DURING A DIAGNOSTIC EVALUATION IN AN EMERGENCY ROOM IN CANADA, A PHYSICIAN ENCOUNTERED A CONNECTIVITY ISSUE WITH CLARIUS ULTRASOUND SCANNER C3 HD3 WHILE ATTEMPTING TO ASSESS A PATIENT PRESENTING WITH ABDOMINAL PAIN AND SUSPECTED FLUID ACCUMULATION. THE MALFUNCTION DID NOT RESULT IN DEATH, SERIOUS INJURY, OR ANY SIGNIFICANT ADVERSE DEVICE-RELATED OUTCOMES. HOWEVER, THE MALFUNCTION CAUSED A DELAY IN DIAGNOSTIC THAT COULD HAVE EXACERBATE THE PATIENT'S CONDITION AND LEAD TO A DEATH, SERIOUS INJURY OR SIGNIFICANT DEVICE EXPERIENCE IF IT WERE TO REOCCUR IN AN EMERGENCY ENVIRONMENT. THE EVENT WAS REPORTED TO CLARIUS ON SEPTEMBER 11TH, 2024 AND THE CLARIUS SCANNER C3 HD3 HAS BEEN CLEARED BY THE FDA UNDER 510(K) #K213436. THE MALFUNCTION IDENTIFIED UNDER THIS REPORT OCCURRED DUE TO A CONNECTION ISSUE BETWEEN CLARIUS APP AND CLARIUS SCANNER BECAUSE OF A CLARIUS APP PILOT UPDATE ( CLARIUS APP 11.3.1 TO CLARIUS APP 11.3.2). THE ISSUE WAS SUCCESSFULLY RESOLVED BY UNINSTALLING AND THEN REINSTALLING THE APPLICATION.