BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD 15 ULTRASOUND SYSTEM

    MDR report key: 3202190 · Received June 28, 2013

    Report

    Report Number
    1218950-2013-02733
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Report Date
    June 3, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IYO
    PMA / PMN Number
    K081661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PHILIPS FIELD SERVICE ENGINEER WENT TO THE CUSTOMER SITE AND REPLACED THE LIFT ASSEMBLY. THE SYSTEM WAS PLACED BACK INTO SERVICE AFTER THE REPAIR. THE PART AFFECTED WAS RETURNED TO THE FACTORY FOR EVALUATION. EVALUATION OF THE RETURNED PART IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE NEW INFORMATION BECOMES AVAILABLE. NO INJURY HAS BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHILIPS HD15 ULTRASOUND SYSTEM'S CONTROL PANEL FELL OFF THE CART DURING AN EXAM. THE EXAM WAS COMPLETED USING ANOTHER SYSTEM. THERE WAS NO INJURY REPORTED AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296128 HD 15 ULTRASOUND SYSTEM IYO, IYN ITX IYO PHILIPS MEDICAL SYSTEMS 795066 US51220259

    Patients

    Seq Age Sex Outcome Treatment
    1