BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEE/8-3 MHZ TRANSDUCER

    MDR report key: 2655830 · Received February 17, 2009

    Report

    Report Number
    3032367-2009-00001
    Event Type
    Malfunction
    Date Received
    February 17, 2009
    Date of Event
    January 13, 2009
    Report Date
    February 13, 2009
    Manufacturer
    SONOSITE, INC.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SONOSITE, INC. HAS CONTACTED THE DISTRIBUTOR AND IS AWAITING THE RETURN OF THE TRANSDUCER FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SCANPLANE OF THEIR TEE TRANSDUCER WOULD NOT ROTATE, BUT WAS STUCK AT 180 DEGREES. THIS EVENT OCCURRED DURING A PATIENT EXAM. THE PHYSICIAN WAS UNABLE TO RECOVER THE FUNCTIONALITY OF THE TRANSDUCER AND HAD TO CANCEL THE PROCEDURE. THERE WAS NO REPORTED INJURY OR ADVERSE EFFECT TO THE PATIENT REPORTED. THE CUSTOMER IS USING THEIR TEE TRANSDUCER WITH A SONOSITE MICROMAXX ULTRASOUND SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEE/8-3 MHZ TRANSDUCER TRANSESOPHEGEAL ULTRASOUND TRANSDUCER IYO SONOSITE, INC. P05183

    Patients

    Seq Age Sex Outcome Treatment
    1