BEUDAMED
    FDA Adverse Event Death Summary report: N

    HD 15 ULTRASOUND SYSTEM

    MDR report key: 6708928 · Received July 12, 2017

    Report

    Report Number
    3019216-2017-00023
    Event Type
    Death
    Date Received
    July 12, 2017
    Date of Event
    June 27, 2017
    Report Date
    June 27, 2017
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    PMA / PMN Number
    K081661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO PERFORM A THOROUGH INSPECTION OF THE HD15 ULTRASOUND SYSTEM AND ISOLATED THE ISSUE TO A POOR USB CONNECTION ON THE PC THAT LEADS TO THE CONTROL PANEL. EVALUATION OF THE DEVICE VERIFIED THE POOR CONNECTION CAUSED THE SYSTEM CONTROL PANEL TO BE UNRESPONSIVE. IT HAS BEEN CONCLUDED THAT THE ULTRASOUND SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE DEATH OF THIS PATIENT. ONCE A SECURE CONNECTION WAS ESTABLISHED, THE SYSTEM OPERATED PROPERLY AND WAS RETURNED TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT HAD EXPIRED IN THE ER AS A RESULT OF AN AORTIC RUPTURE, THE MEDICAL TEAM WAS UNABLE TO USE THEIR HD15 ULTRASOUND SYSTEM TO EVALUATE THE PATIENT DUE TO AN UNRESPONSIVE CONTROL PANEL. A HEALTH PROFESSIONAL AT THE SITE STATED THAT THIS OUTCOME WAS IMMINENT BASED UPON THE PATIENT'S CRITICAL STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489093 HD 15 ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC22 IYN PHILIPS ULTRASOUND, INC 795066 US71023449

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death