BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONOSITE S SERIES ULTRASOUND SYSTEM, S1.6

    MDR report key: 6576814 · Received May 18, 2017

    Report

    Report Number
    3032367-2017-00001
    Event Type
    Injury
    Date Received
    May 18, 2017
    Date of Event
    April 18, 2017
    Report Date
    May 15, 2017
    Manufacturer
    FUJIFILM SONOSITE, INC. BOTHELL, WA
    Product Code
    IYN
    PMA / PMN Number
    K130173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE STAND IN QUESTION HAS BEEN HIGHLY MODIFIED AND IS NOT CONFIGURED IN AN APPROVED CONFIGURATION AS OUTLINED IN THE DEVICE USER GUIDE. THE CUSTOMER PROVIDED AN IMAGE OF THE STAND CONFIGURATION WHICH SHOWS THAT SEVERAL OTHER ELECTRICAL DEVICES HAVE BEEN ATTACHED TO IT AND INTEGRATED ELECTRICALLY. THE ADDITIONAL ELECTRICAL DEVICES INCLUDE A SAMSUNG TABLET AND A VPS VASANOVA VASCULAR DEVICE. THE ADDITION OF THESE DEVICES AND ALSO THE ADDITION OF A SEPARATE MECHANICAL ARM HAVE DRASTICALLY ALTERED THE CONFIGURATION OF THE STAND WITH WHICH THE ULTRASOUND DEVICE IS USED. THE USER GUIDE SPECIFICALLY STATES ON PAGE 9: "TO AVOID POSSIBLE ELECTRICAL SHOCK OR ELECTROMAGNETIC INTERFERENCE, VERIFY PROPER OPERATION AND COMPLIANCE WITH RELEVANT SAFETY STANDARDS FOR ALL EQUIPMENT BEFORE CLINICAL USE. CONNECTING ADDITIONAL EQUIPMENT TO THE ULTRASOUND SYSTEM CONSTITUTES CONFIGURING A MEDICAL SYSTEM. SONOSITE RECOMMENDS VERIFYING THAT THE SYSTEM, ALL COMBINATIONS OF EQUIPMENT, AND ACCESSORIES CONNECTED TO THE ULTRASOUND SYSTEM COMPLY WITH JACHO INSTALLATION REQUIREMENTS AND/OR SAFETY STANDARDS AAMI-ES1, NFPA 99, IEC 60601-1-1, AND IEC 60601-1-2, AND ARE CERTIFIED ACCORDING TO IEC 60950. (INFORMATION TECHNOLOGY EQUIPMENT (ITE))." AS THE CUSTOMER HAS IMPROPERLY CONFIGURED THE STAND AND ADDED TECHNOLOGICAL DEVICES OF UNKNOWN ELECTRICAL ORIENTATIONS AND CONDITIONS, THE CAUSE OF THE REPORTED ISSUE HAS BEEN ATTRIBUTED TO USE ERROR.

    Description of Event or Problem · 1

    A DEVICE USER ALLEGED THAT, WHILE PUSHING THE ULTRASOUND DEVICE STAND, SHE RECEIVED A SEVERE SHOCK. THE EXTENT OF THE INJURIES/EFFECTS SUSTAINED FROM THE EVENT HAVE BEEN REQUESTED BUT NOT REPORTED BY THE USER. IT WAS REPORTED THAT THE USER HAS MISSED WORK DUE TO THE EFFECTS OF THE ALLEGED SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357765 SONOSITE S SERIES ULTRASOUND SYSTEM, S1.6 DIAGNOSTIC ULTRASOUND SYSTEM IYN FUJIFILM SONOSITE, INC. BOTHELL, WA P09417-65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other