BEUDAMED
    FDA Adverse Event Other Summary report: N

    CX50 ULTRASOUND SYSTEM

    MDR report key: 2396687 · Received December 29, 2011

    Report

    Report Number
    3019216-2011-00017
    Event Type
    Other
    Date Received
    December 29, 2011
    Report Date
    November 30, 2011
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    PMA / PMN Number
    K081802
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. NO DEATH OR SERIOUS INJURY WERE REPORTED. A PRODUCT MALFUNCTION HAS NOT BEEN CONFIRMED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ULTRASOUND TECHNICIAN RECEIVED A MINOR BURN ON HER FINGERS WHILE LATCHING THE TRANSDUCER TO THE CX50 ULTRASOUND SYSTEM. NO OTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. PHILIPS IS WAITING FOR THE RETURN OF THE CX50 ULTRASOUND SYSTEM FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CX50 ULTRASOUND SYSTEM IYO, IYN, ITX IYO PHILIPS ULTRASOUND, INC. 795064 US90901347

    Patients

    Seq Age Sex Outcome Treatment
    1 Other