BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARIUS ULTRASOUND SCANNER

    MDR report key: 20471171 · Received October 17, 2024

    Report

    Report Number
    2023204-2024-00001
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    September 5, 2024
    Report Date
    October 7, 2024
    Manufacturer
    CLARIUS MOBILE HEALTH CORP.
    Product Code
    IYN
    UDI-DI
    07540205001189
    PMA / PMN Number
    K213436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288118 CLARIUS ULTRASOUND SCANNER DIAGNOSTIC ULTRASOUND SYSTEM AND ACCESSORIES IYN CLARIUS MOBILE HEALTH CORP. C3 HD3 07540205001189

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown