BEUDAMED
    FDA Adverse Event Death Summary report: N

    CX50 ULTRASOUND SYSTEM

    MDR report key: 3034510 · Received April 1, 2013

    Report

    Report Number
    3019216-2013-00003
    Event Type
    Death
    Date Received
    April 1, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 4, 2013
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    PMA / PMN Number
    K081802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CX50 ULTRASOUND SYSTEM WAS EVALUATED BY THE BIO-ENGINEER FROM THE HEALTHCARE ALONG WITH A PHILIPS FIELD SERVICE ENGINEER. THE SYSTEM LOGS WERE ALSO REVIEWED. EVALUATION OF THE SYSTEM AND LOGS CONFIRMED NORMAL SYSTEM OPERATION. A MEDICAL PROFESSIONAL FROM THE HEALTHCARE FACILITY CONFIRMED THERE WAS NO CAUSAL CORRELATION BETWEEN THE PT DEATH AND THE CX50 ULTRASOUND SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CX50 ULTRASOUND SYSTEM FAILED DURING AN EXAMINATION IN THE ICU, BUT THE CLINICIAN WAS ABLE TO COMPLETE THE PROCEDURE. DESPITE THE CLINICIAN BEING ABLE TO COMPLETE THE PROCEDURE THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132743 CX50 ULTRASOUND SYSTEM IYO IYN ITX IYO PHILIPS ULTRASOUND, INC. 795064 US70901164

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death