BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEE/8-3 MHZ TRANSDUCER

    MDR report key: 2123200 · Received August 29, 2008

    Report

    Report Number
    3032367-2008-00002
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    July 31, 2008
    Manufacturer
    SONOSITE, INC.
    Product Code
    IYO
    PMA / PMN Number
    K071134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH OUR TEST METHODS HAVE NOT BEEN ABLE TO DUPLICATE THE FAILURE MODE WHEN A TEE TRANSDUCER IS CONNECTED DIRECTLY TO AN M-TURBO SYSTEM WITHOUT THE USE OF A TTC, ENGINEERING ANALYSIS HAS REVEALED A SMALL POTENTIAL FOR THIS SITUATION TO OCCUR. FURTHER TESTING OF THE TEE TRANSDUCER CONNECTED WITH A MICROMAXX SYSTEM VERIFIED THAT THE TEE TRANSDUCERS BEHAVE AS EXPECTED. THE BEHAVIOR ONLY MANIFESTS ITSELF WHEN USED WITH AN M-TURBO SYSTEM, SOFTWARE VERSION 1.1.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR M-TURBO SYSTEM STOPPED REACTING AND LOCKED UP WHILE CONNECTED TO THEIR TEE/8-3 TRANSDUCER. THIS OCCURRED DURING A PT EXAM. NO INJURIES HAVE BEEN REPORTED. ATTEMPTS TO OBTAIN ADD'L INFO FROM THE CUSTOMER HAVE THUS FAR BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEE/8-3 MHZ TRANSDUCER TRANSESOPHAGEAL ULTRASOUND TRANSDUCER IYO SONOSITE, INC. P06841-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other