BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON

    MDR report key: 4919558 · Received July 13, 2015

    Report

    Report Number
    3009498591-2015-00201
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 8, 2015
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA INC.
    Product Code
    IYN
    PMA / PMN Number
    072786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS REPRESENTATIVE WAS NOTIFIED OF THE SC2000 BEING DOWN AND ARRIVED ON-SITE 7/8. DURING HIS VISIT, THE SITE MENTIONED THE PATIENT OUTCOME, BUT NOT AS A RESULT OF THE SYSTEM ISSUE. HE SAID "SC2000 WAS NOT INVOLVED NOR CONTRIBUTED TO THE PATIENT'S DEATH. THE PATIENT'S DEATH WAS NOT RELATED TO THE DELAY OF IMAGES BEING SENT TO PACS". HE WAS ON-SITE AGAIN YESTERDAY 7/9, AND NOTHING WAS MENTIONED REGARDING THE INCIDENT. THE SYSTEM ISSUE WAS RESOLVED AND ROOT CAUSE WAS RELATED TO THE USER SHUTTING DOWN WHILE THE SYSTEM IS IN SCREEN SAVER MODE."

    Description of Event or Problem · 1

    THE IMAGES WERE COLLECTED AND BROUGHT BACK TO THE DEPARTMENT. ONCE BACK IN THE DEPARTMENT, WHEN THEY TRIED TO TURN THE SYSTEM BACK ON, IT WOULD NOT BOOT. MEANWHILE, THE PATIENT HAD EXPIRED. THE PATIENT'S DEATH WAS NOT RELATED TO THE DELAY IN TRANSFERRING THE IMAGES. AFTER THE SYSTEM WAS SERVICED, THE IMAGES WERE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452853 ACUSON DIAGNOSTIC ULTRASOUND DEVICE IYN SIEMENS MEDICAL SOLUTIONS USA INC. ACUSON SC2000

    Patients

    Seq Age Sex Outcome Treatment
    1