BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE VLOUSON 730

    MDR report key: 963345 · Received May 10, 2007

    Report

    Report Number
    8020021-2007-00004
    Event Type
    Malfunction
    Date Received
    May 10, 2007
    Date of Event
    March 25, 2007
    Report Date
    May 10, 2007
    Manufacturer
    GE KRETZTECHNIK GMBH & CO. OHG
    Product Code
    IYO
    PMA / PMN Number
    K041688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE COULD ONLY BE REPRODUCED WITH EXTENSIVE THERMAL CYCLING AND VIBRATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE THAT THE ULTRASOUND TRANSDUCER OVERHEATED ON A SYSTEM THAT WAS UNDERGOING REFURBISHMENT AND UPGRADE. THE SYSTEM HAD NOT YET BEEN DELIVERED TO A CUSTOMER AND NO INJURY RESULTED. INVESTIGATION OF THE MALFUNCTION IDENTIFIED A CAUSE WHICH COULD POSSIBLY OCCUR DURING ACTUAL CLINICAL USE. SINCE THIS WAS AN INVASIVE TRANSDUCER, THERE WOULD BE LITTLE OPPORTUNITY FOR THE USER OR THE PT TO INTERVENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE VLOUSON 730 DIAGNOSTIC ULTRASOUND IYO GE KRETZTECHNIK GMBH & CO. OHG 730 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *