BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ 7C - 795201

    MDR report key: 3899268 · Received May 16, 2014

    Report

    Report Number
    3019216-2014-00010
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Report Date
    April 18, 2014
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PHILIPS ENGINEER PERFORMED A VISUAL INSPECTION AND CONCLUDED THAT AN INTERNAL SHORT WITHIN THE SYSTEM BATTERY CAUSED THE MALFUNCTION. THE BATTERY MANUFACTURER IS PERFORMING A FAILURE ANALYSIS ON THE BATTERY TO DETERMINE THE CAUSE OF THE FAILURE. A FOLLOW-UP REPORT WILL BE SUBMITTED FOLLOWING THE INVESTIGATION COMPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT AN EPIQ 7C SYSTEM BEGAN TO EMIT SMOKE FROM THE BATTERY ENCLOSURE AREA SHORTLY AFTER THE CUSTOMER PLUGGED THE SYSTEM INTO THE POWER OUTLET. THE SYSTEM STOPPED SMOKING AFTER IT WAS UNPLUGGED. NO MEDICAL INTERVENTION WAS REQUIRED AND THERE WAS NO REPORT OF ANY INJURY OR IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294769 EPIQ 7C - 795201 IYO IYN ITX IYO PHILIPS ULTRASOUND, INC. EPIQ 7C - 795201 US513B0322

    Patients

    Seq Age Sex Outcome Treatment
    1