BEUDAMED
    FDA Adverse Event Other Summary report: N

    CX50 ULTRASOUND SYSTEM

    MDR report key: 3978810 · Received July 9, 2014

    Report

    Report Number
    3019216-2014-03915
    Event Type
    Other
    Date Received
    July 9, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    PMA / PMN Number
    K081802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION BY THE PHILIPS FIELD SERVICE ENGINEER REVEALED A LOOSE SCREW INSIDE THE SYSTEM MADE CONTACT WITH A VOLTAGE SOURCE ON THE MOTHERBOARD CAUSING A TEMPERATURE RISE IN THE TRANSDUCER LATCH. THERE WAS NO REPORT OF ANY SERIOUS INJURY ONLY MINOR BURN TO THE FINGERTIP WHEN THE DOCTOR REMOVED THE TRANSDUCER ADAPTER. THIS SYSTEM WAS SHIPPED IN 2008 PRIOR TO THE IMPLEMENTATION OF AN ENHANCED FASTENER INSTALLED ON ALL CX50 SYSTEMS SHIPPED AFTER (B)(6) 2010.

    Description of Event or Problem · 1

    A MINOR FINGERTIP BURN WAS RECEIVED BY THE DOCTOR WHILE ATTEMPTING TO REMOVE THE TRANSDUCER ADAPTER FROM THE CX50 ULTRASOUND SYSTEM. NO SERIOUS INJURY OCCURRED. OINTMENT WAS APPLIED TO THE FINGER AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402212 CX50 ULTRASOUND SYSTEM IYO IYN ITX IYO PHILIPS ULTRASOUND, INC. 795064 USA0800388

    Patients

    Seq Age Sex Outcome Treatment
    1