BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON SEQUOIA C512 ULTRASOUND SYSTEM

    MDR report key: 7075132 · Received December 1, 2017

    Report

    Report Number
    3009498591-2017-00520
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    July 19, 2017
    Report Date
    December 1, 2017
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYN
    PMA / PMN Number
    K052410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO SIEMENS FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED OR IF THE DEVICE IS RETURNED AT A LATER DATE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    SIEMENS MEDICAL SOLUTIONS, USA, INC. RECEIVED A MEDWATCH REPORT # (B)(4). IT WAS REPORTED BY THE USER FACILITY THAT AN OUT-PATIENT PRESENTED AT THE HOSPITAL FOR A STRESS ECHOCARDIOGRAM. REPORTEDLY, THE OPERATOR OBTAINED THE PATIENTS' PRE-IMAGES AND HAD SUCCESSFULLY SAVED THEM. AFTER THE PATIENT FINISHED WALKING ON THE TREADMILL, THE USER NEEDED TO TAKE POST IMAGES WITHIN TWO MINUTES AFTER THE WALK BEFORE THE PATIENTS' HEART RATE DROPPED. HOWEVER, THE ULTRASOUND SYSTEM FROZE AND BECAME INOPERABLE. THE PHYSICIAN WHO WAS IN THE ROOM DURING THE TEST ABORTED, THE ECHOCARDIOGRAM. THE TEST WAS REPORTED TO BE INCOMPLETE. NO ADDITIONAL INFORMATION WAS PROVIDED. MULTIPLE ATTEMPTS WERE MADE VIA EMAIL AND TELEPHONE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED PHENOMENON BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855787 ACUSON SEQUOIA C512 ULTRASOUND SYSTEM ULTRASOUND DEVICE IYN SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON SEQUOIA 512 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1