BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEEX/8-3 MHZ

    MDR report key: 2427846 · Received January 11, 2012

    Report

    Report Number
    3032367-2012-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Report Date
    November 18, 2011
    Manufacturer
    SONOSITE,INC.
    Product Code
    IYO
    PMA / PMN Number
    K082098
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN SPEAKING WIT THE INITIAL REPORTER AND BIOMEDICAL TECHNICIAN, BOTH CONFIRMED NO PTS WERE INJURED OR HARMED DURING THE INCIDENT. THE MEDWATCH FORM (B)(4) SUBMITTED BY THE USER FACILITY DESCRIBES THE EVENT. SONOSITE HAS MADE SEVERAL ADD'L ATTEMPTS TO COLLECT SPECIFIC INFO REGARDING THE PT'S CIRCUMSTANCE; HOWEVER, THE USER FACILITY HAS NOT YET RESPONDED. ALTHOUGH SONOSITE DOES NOT BELIEVE THIS INCIDENT MEETS THE DEFINITION OF AN MDR REPORTABLE EVENT, WE HAVE INCLUDED SONOSITE'S INVESTIGATION RESULTS OF THE TRANSDUCER AND SYSTEM INVOLVED. THE CUSTOMER RETURNED THEIR TEEX/8-3 MHZ TRANSDUCER (S/N (B)(4)) FOR ROUTINE EVAL ON (B)(6) 2011, PRIOR TO OUR KNOWLEDGE OF THIS MDR (RECEIVED (B)(4) 2011). FURTHER TESTING CONFIRMED THAT THE TRANSDUCER'S MOTOR HAD NO FUNCTION, THE MOTOR HANDLE WAS MAKING NOISE, AND THE INTERNAL ARRAY ATTEMPTED TO MOVE BUT WAS SLIPPING/STUCK. WHEN THE TRANSDUCER WAS CONNECTED TO A REFERENCE M-TURBO SYSTEM DURING A HOT OR COLD CONNECTION, THE SYSTEM ASSERTED 9071, WHICH IS THE EXPECTED SYSTEM RESPONSE OF ARRAY SLIPPAGE. THE CUSTOMER ALSO RETURNED THEIR M-TURBO SYSTEM (S/N (B)(4)) FOR EVAL ON (B)(4) 2011. THE SYSTEM PASSED ALL FUNCTIONAL TESTING. HOWEVER, WHEN CONNECTED WITH THE TEEX TRANSDUCER IN QUESTION, THE SYSTEM ASSERTED 9071. THEREFORE, WE ARE CERTAIN THE FAILURE WAS CAUSED BY THE TEEX PROBE, NOT THE SYSTEM. THE TEEX TRANSDUCER WILL BE SENT TO THE ORIGINAL EQUIPMENT MFR FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEEX/8-3 MHZ TRANSDUCER, ULTRASONIC, DIAGNOSTIC IYO SONOSITE,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1