BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEE/8-3 MHZ TRANSDUCER

    MDR report key: 2228253 · Received September 12, 2008

    Report

    Report Number
    3032367-2008-00004
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 6, 2008
    Report Date
    September 12, 2008
    Manufacturer
    SONOSITE, INC.
    Product Code
    IYO
    PMA / PMN Number
    K071134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    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 THE ANGLE OF THE SCANNING AREA IS ONLY ABLE TO MOVE ONE WAY AND DOES NOT REACT BY PRESSING THE SWITCH TOWARDS THE CABLE. THERE WAS NO REPORT OF PATIENT INJURY. THE TEE TRANSDUCER GUIDE RECOMMENDS THAT THE CUSTOMER PERFORM BOTH A VISUAL INSPECTION OF THE TRANSDUCER AS WELL AS A SCANPLANE ROTATION INSPECTION PRIOR TO EACH USE. THE REPORTED FAILURE MAY HAVE BEEN OBSERVED DURING THIS TYPE OF FAILURE MAY HAVE BEEN OBSERVED DURING THIS TYPE OF ROUTINE INSPECTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other