BEUDAMED
    FDA Adverse Event Summary report: N

    CX50 ULTRASOUND SYS

    MDR report key: 3841305 · Received May 15, 2014

    Report

    Report Number
    3019216-2014-02622
    Date Received
    May 15, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 15, 2014
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    PMA / PMN Number
    K081802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHILE AT THE CUSTOMER SITE FOR SCHEDULED REPAIR OF THE SYSTEM, THE FIELD SERVICE ENGINEER (FSE) NOTICED THE BATTERY SWOLLEN AND THE BATTERY CASE SEPARATED. THE FSE REPLACED THE BATTERY. THE BATTERY IS CURRENTLY BEING INVESTIGATED BY THE SUPPLIER FOR ROOT CAUSE.

    Description of Event or Problem · 1

    WHILE SERVING THE ULTRASOUND SYSTEM, THE FSE DISCOVERED THE PLASTIC HOUSING OF THE CX50 SEPARATED ALONG THE WELD LINE. THERE WAS NO INJURY REPORTED AND NO LEAKAGE OF BATTERY CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289650 CX50 ULTRASOUND SYS IYO IYN ITX IYO PHILIPS ULTRASOUND, INC. 795064 SGO1001042

    Patients

    Seq Age Sex Outcome Treatment
    1