BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X7-2T TRANSDUCER (MTEE)

    MDR report key: 3960139 · Received June 24, 2014

    Report

    Report Number
    3019216-2014-00012
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    PMA / PMN Number
    K030455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE TRANSDUCER WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS RETURN.

    Description of Event or Problem · 1

    A DAMAGED PROBE CAUSED A MINOR ESOPHAGEAL SCRATCH. NO MEDICAL INTERVENTION WAS REQUIRED NOR DID THIS CAUSE AN EXTENSION OF MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367182 X7-2T TRANSDUCER (MTEE) IYO, IYN, ITX IYO PHILIPS ULTRASOUND, INC. 989605350451 03F5HH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR