BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEE/8-3 MHZ TRANSDUCER

    MDR report key: 2655821 · Received August 22, 2008

    Report

    Report Number
    3032367-2008-00001
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 29, 2008
    Manufacturer
    SONOSITE, INC.
    Product Code
    IYO
    PMA / PMN Number
    K071134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. THE CUSTOMER WAS ADVISED TO NOT USE THEIR TEE TRANSDUCER WITH THEIR M-TURBO SYSTEM. THEY CURRENTLY HAVE MICROMAXX LOANER SYSTEMS. ADDITIONALLY, THEY WERE ADVISED TO TEST THEIR TEE TRANSDUCER TO VERIFY THE ANGLE WAS ADJUSTING AS EXPECTED PRIOR TO USE, AS INSTRUCTED IN THE USER GUIDE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THREE OF THE ANESTHESIOLOGISTS ON SITE HAD REPORTED THAT WHEN ATTEMPTING TO ADJUST THE ANGLE ON THEIR TEE TRANSDUCER, WHEN THE TEE WAS ADJUSTED PAST 94 DEGREES, THE ANGLE WOULD JUMP TO 180 DEGREES INSTEAD OF MOVING IN INCREMENTS OF ONE. WHEN ADJUSTING BACK DOWN FROM 180 DEGREES, THEY FOUND THAT THE ANGLE WOULD AGAIN JUMP DOWN TO 94 DEGREES. ADJUSTMENTS MADE IN THE RANGE BELOW 94 DEGREES MOVED IN SINGLE INCREMENTS AS EXPECTED. THIS ISSUE OCCURRED MID-PROCEDURE ON THREE DIFFERENT PATIENTS. PER THE CUSTOMER, THERE WERE NO INJURIES OR NEGATIVE IMPACT TO THE PATIENT OBSERVED AS A RESULT OF THIS FAILURE. THE CUSTOMER ATTEMPTED TO TROUBLESHOOT THE PROBLEM ON THEIR OWN AND WERE UNABLE TO DUPLICATE THE PROBLEM. THEY CONTACTED SONOSITE TECHNICAL SUPPORT AND FOUND THAT WHEN USED IN PORT 2 OF THEIR TTC, THE TRANSDUCERS OPERATED AS EXPECTED. HOWEVER, THEY WERE ABLE TO DUPLICATE THE ISSUE IN PORTS 1 AND 3.

    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