BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASONOGRAPHY

    MDR report key: 822740 · Received February 18, 2007

    Report

    Report Number
    MW1042029
    Event Type
    Injury
    Date Received
    February 18, 2007
    Date of Event
    November 15, 2006
    Report Date
    February 18, 2007
    Manufacturer
    SONOSITE
    Product Code
    IYN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE VETERINARY TEACHING HOSP HAS RECENTLY BOUGHT A 'SONOSITE MICROMAX' ULTRASONOGRAPHIC MACHINE/ USA -REF: P05361-01 WITH THREE LINEAR, CURVE, AND PHASE ARRAY TRANSDUCERS FROM 'IDEA INC COMPANY' RESPRESENTING THE MENTIONED COMPANY IN ITS COUNTRY. UNFORTUNATELY, WHILE THE EQUIPMENT AND ITS LINEAR TRANSDUCER -HFL 38/13-6 MHZ, REF: P05697-10 WAS TESTED BY ONE OF THE ACADEMIC STAFF OF THE DEPT ON HIS OWN HAND, BURNING AND SUPERFICIAL EMBOLI TOOK PLACE NEAR HIS ELBOW JOINT. AFTERWARD, THE SAME EXPERIENCE WAS SENSED BY THE OTHER COLLEAGUES. ACCORDING TO THE USERS' CLAIMS, THE SURFACE OF THE PROBE HAD BEEN MILDLY WARMED BUT THE BURNING SEEMED NOT TO BE DUE TO THAT. THE CASE WAS IMMEDIATELY REPORTED TO THE MFR OF THE EQUIPMENT BY E-MAIL AND SUBSEQUENTLY THE COMPANY SENT ITS AGENT AS ITS REP TO DISPATCH THE TRANSDUCERS TO THEM AND ANOTHER ONE -SONOSITE MICROMAX REF: P06468-02 WITH HFL38/13-6 MHZ TRANSDUCER REF: PO5697-10 TEMPORARILY REPLACED. AFTER INVESTIGATING THE SYSTEM AND THE TRANSDUCERS, THE REPRESENTATIVE CLAIMED THAT THERE WERE NO PROBLEMS DETECTED. HOWEVER, THE SUBSTITUTED SYSTEM ALSO MADE SKIN BURNING IN A PIGEON AND IT CAUSED EMBOLI AND VAST DERMAL HEMORRHAGE ON THE SKIN SURFACE OF A REFERRED DOG TO THE HOSPITAL. DESPITE SENDING THE PICTURES OF THE CASES, THERE WERE NO ACCEPTABLE EXPLANATIONS. IT WOULD BE REQUISITE TO SAY THAT IN OUR VETERINARY HOSP, LIKE THE OTHER WORLD'S HOSPS, MEDICAL ULTRASONOGRAPHIC MACHINES ARE USED NORMALLY IN VETERINARY PRACTICE TOO, AND THERE HAS NOT BEEN SUCH A PROBLEM REPORTED YET. NEVERTHELESS, THE COMPLICATIONS MADE BY "SONOSITE MICROMAX' ULTRASONOGRAPHIC MACHINES HAD OCCURRED ON THE HAND OF ONE OF THE ACADEMIC STAFFS PRIMARILY. THE FINAL ADVISE OF THE SONOSITE REPRESENTATIVE WAS TO USE THE DOPPLER SONOGRAPHY ON AN AREA NOT MORE THAN 2 MINS!! THEREFORE, IT IS KINDLY REQUESTED THAT FIRSTLY, FOR THE PUBLIC HEALTH, PLEASE ORDER TO REVISE SAFETY OF THE MACHINE AND SECONDLY, PLEASE ORDER TO THE COMPANY TO COMPENSATE THE LOSS OF THIS FACILITY. I CAN SEND YOU DOCUMENT PHOTO FILES OF THE PREVIOUS CORRESPONDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASONOGRAPHY DIAGNOSTIC ULTRASONOGRAPHY MACHINE 6-13 MHZ IYN SONOSITE MICROMAX *
    2 ULTRASONOGRAPHY DIAGNOSTIC ULTRASONOGRAPHY MACHINE 6-13 MHZ IYN SONOSITE MICROMAX *
    3 ULTRASONOGRAPHY DIAGNOSTIC ULTRASONOGRAPHY MACHINE 6-13 MHZ IYN SONOSITE MICROMAX *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| O TRANSDUCER OF THE 1ST ULTRASONOGRAPHY MACHINE:| HFL 38/13-6 MHZ, REF: P05697-10| HFL 38/13-6 MHZ, TRANSDUCER REF: P05697-10| TRANSDUCER OF THE 2ND ULTRASONOGRAPHY MACHINE: