BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-PORTE ULTRASOUND SYSTEM, TTC AND STAND, PRINTER READY, 1.0.7, ROHS

    MDR report key: 7043431 · Received November 17, 2017

    Report

    Report Number
    3032367-2017-00002
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    October 19, 2017
    Report Date
    February 22, 2018
    Manufacturer
    FUJIFILM SONOSITE, INC.
    Product Code
    IYN
    PMA / PMN Number
    K133134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STAND POWER MANAGEMENT UNIT (SPMU) WAS EVALUATED AND THE REPORTED ISSUE WAS ABLE TO BE DUPLICATED. A TEST AC POWER CORD WAS INSERTED INTO THE SPMU AND AN AUDIBLE "SPARK" NOISE WAS OBSERVED PRIOR TO THE CORD BEING INSERTED INTO THE AC RECEPTACLE. A VOLTAGE METER WAS ATTACHED AT THE TIME AND THE VOLTAGE OUTPUT WAS REPORTED AT APPROXIMATELY 24 VOLTS OF DIRECT CURRENT (VDC), WHICH IS THE EXPECTED VOLTAGE OUTPUT. HOWEVER, UPON FURTHER EVALUATION, IT WAS OBSERVED THAT ONE OR BOTH OF THE RECEPTACLE CONTACT PLATES (LINE AND NEUTRAL) WERE NOT MAINTAINING CONSISTENT CONTACT. AS A RESULT, IF AN AC CORD IS NOT FULLY INSERTED INTO THE RECEPTACLE, ARCING IS POSSIBLE AND SMALL BURN MARKS ARE OBSERVED ON THE AC POWER CORD LINE CONTACT. THE VOLTAGE, HOWEVER, IS NOT ABOVE THE EXPECTED 24 VDC AND NO SIGNIFICANT ELECTRICAL HARM IS LIKELY TO OCCUR AS A RESULT OF THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    FURTHER DETAILS REGARDING THE REPORTED FAILURE WAS REQUESTED OF THE CUSTOMER. HOWEVER, TO DATE, THE CUSTOMER HAS NOT PROVIDED FURTHER INFORMATION. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT POWER MODULE TO RESOLVE THE REPORTED ISSUE. THE FAULTY POWER MODULE/CORD HAS NOT BEEN RETURNED FOR EVALUATION. IF THE CUSTOMER RETURNS THE FAULTY POWER MODULE/CORD IN THE FUTURE, A THOROUGH EVALUATION FOR ROOT CAUSE WILL BE COMPLETED AND A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY OBSERVED A SPARK NEAR/AROUND THE POWER CORD OF THEIR DEVICE, AT THE DEVICE END OF THE POWER CORD. AT THE TIME OF THE EVENT, NO ACTIONS WERE BEING TAKEN AND NO PATIENT WAS PRESENT. THE DEVICE WAS NOT IN USE DURING THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY OBSERVED A SPARK NEAR/AROUND THE POWER CORD OF THEIR DEVICE, AT THE DEVICE END OF THE POWER CORD. AT THE TIME OF THE EVENT, NO ACTIONS WERE BEING TAKEN AND NO PATIENT WAS PRESENT. THE DEVICE WAS NOT IN USE DURING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820064 X-PORTE ULTRASOUND SYSTEM, TTC AND STAND, PRINTER READY, 1.0.7, ROHS DIAGNOSTIC ULTRASOUND SYSTEM IYN FUJIFILM SONOSITE, INC. P19220-54

    Patients

    Seq Age Sex Outcome Treatment
    1