BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSOUND ALPHA-10

    MDR report key: 3140820 · Received May 30, 2013

    Report

    Report Number
    3140820
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 30, 2013
    Manufacturer
    HITACHI ALOKA MEDICAL LTD.
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING EGD/EUS, ULTRASOUND MACHINE MALFUNCTIONED. COULD NOT OBTAIN CLEAR IMAGES TO PERFORM EUS/FNA SAFELY. VENDOR NOTIFIED FOR TROUBLE SHOOTING OF THE DEVICE. UNABLE TO RESOLVE PROBLEM. VENDOR TO COME TO THE SITE. OLYMPUS AND ALOKA EVALUATED DEVICE AND WERE UNABLE TO DUPLICATE PROBLEM. HAVE SINCE IDENTIFIED POTENTIAL PROBLEM WITH A CABLE THAT HAS BEEN FIXED.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238672 PROSOUND ALPHA-10 SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN HITACHI ALOKA MEDICAL LTD. SSD-ALPHA10 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR