BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON SEQUOIA SYSTEM

    MDR report key: 1133763 · Received August 13, 2008

    Report

    Report Number
    1133763
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 13, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    THE CARDIOLOGIST AND ULTRASOUND TECHNICIAN WERE PERFORMING A TRANS ESOPHEGAL ECHOCARDIOGRAM (TEE) BUBBLE STUDY USING A SIEMENS (ACUSON) SEQUOIA ULTRASOUND SYSTEM. AT THE CONCLUSION OF THE STUDY, BOTH VERIFIED THAT THERE WERE 12 PAGES OF PATIENT DATA STORED FOR THIS PATIENT. THE STUDY WAS SAVED TO THE HARD DRIVE OF THE SYSTEMS COMPUTER. THE ULTRASOUND SYSTEM WAS TURNED OFF CORRECTLY AND RETURNED TO ITS STORAGE LOCATION. WHEN THE ULTRASOUND TECHNICIAN STARTED THE SYSTEM AND ATTEMPTED TO RETRIEVE THE STUDY IN QUESTION, SHE DISCOVERED THAT THERE WERE ONLY NINE PAGES OF PATIENT INFORMATION AVAILABLE. THREE PAGES WERE MISSING. A FIELD ENGINEER WAS DISPATCHED TO ANALYZE THE PROBLEM. THE FIELD ENGINEER INFORMED THE ULTRASOUND TECHNICIAN THAT THE HARD DRIVE IN THE SYSTEMS COMPUTER HAD MALFUNCTIONED. THE HARD DRIVE WAS REPLACED, BUT THE MISSING PATIENT INFORMATION COULD NOT BE RECOVERED. THE FIELD ENGINEER INFORMED THE TECHNICIAN THAT THIS PROBLEM WAS NOT UNCOMMON AMONG OTHER SYSTEMS OF THE SAME MAKE AND MODEL. HE ALSO INFORMED THE TECHNICIAN THAT THIS INCIDENT WOULD BE REPORTED TO THE FDA BY SIEMENS MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUSON SEQUOIA SYSTEM UITRASOUND SYSTEM ITX SIEMENS MEDICAL SOLUTIONS USA, INC. SEQUOIA 512 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR