BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-TURBO ULTRASOUND SYSTEM, 1.7

    MDR report key: 7290447 · Received February 22, 2018

    Report

    Report Number
    3032367-2018-00001
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    January 23, 2018
    Report Date
    February 21, 2018
    Manufacturer
    FUJIFILM SONOSITE, INC.
    Product Code
    IYN
    PMA / PMN Number
    K071134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EPS AND ULTRASOUND DEVICE WERE RETURNED TO SONOSITE FOR FURTHER EVALUATION. THE EPS WAS STILL IN FUNCTIONING ORDER AND WAS ABLE TO CHARGE A TEST BATTERY WITHOUT ANY ISSUES OBSERVED. THE ULTRASOUND DEVICE AND EPS WERE BOTH RUN THROUGH A FUNCTIONAL ACCEPTANCE TESTS (FAT), WHICH INCLUDED CURRENT AND ELECTRICAL TESTING, AND NO RELEVANT FAILURES WERE OBSERVED. THEREFORE, THE CAUSE OF THE REPORTED FIRE INCIDENT COULD NOT BE DETERMINED. THE CUSTOMER DID NOT RETURN THE DAMAGED MINIDOCK AS IT IS STILL FUNCTIONAL AND WAS NOT REPLACED UNDER WARRANTY. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT EPS AND BATTERY TO RESOLVE THE REPORTED ISSUE. CUSTOMER UNWILLING TO SEND DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR M-SERIES MINIDOCK STAND AND EXTERNAL POWER SUPPLY (EPS) CAUGHT FIRE AT THE POINT THE EPS CONNECTS TO THE STAND. THE DEVICE WAS NOT IN USE AT THE TIME AND NO PATIENT OR USER WAS IN THE VICINITY WHEN THE FIRE STARTED. IT IS UNKNOWN IF THE DEVICE WAS PLUGGED INTO AN AC OUTLET AT THE TIME OF THE INCIDENT. THE NEW YORK FIRE DEPARTMENT WAS CALLED TO THE SCENE BUT NO INJURIES OR BODILY HARM WERE REPORTED TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134145 M-TURBO ULTRASOUND SYSTEM, 1.7 DIAGNOSTIC ULTRASOUND SYSTEM IYN FUJIFILM SONOSITE, INC. P08189-83

    Patients

    Seq Age Sex Outcome Treatment
    1