BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IU22 ULTRASOUND SYSTEM

    MDR report key: 1993706 · Received January 13, 2011

    Report

    Report Number
    3019216-2011-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 2, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IYO
    PMA / PMN Number
    K042540
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NO REPORTS OF INJURY OR MISDIAGNOSIS. THE COMPLAINT IS STILL UNDER INVESTIGATION. AT THIS TIME NO PRODUCT MALFUNCTION HAS BEEN CONFIRMED. A FOLLOW-UP REPORT WILL BE PROVIDED WHEN THE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PHILIPS HEALTHCARE QUALITY AND REGULATORY DEPT RECEIVED A CUSTOMER COMPLAINT FROM (B)(6) REGARDING OLDER EXAM/DIFFERENT PT'S DATA BEING ASSIMILATED ONTO ONE PT'S EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IU22 ULTRASOUND SYSTEM IU22 IYO PHILIPS HEALTHCARE IU22 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other