BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOSHIBA INFINIX I

    MDR report key: 3252425 · Received July 23, 2013

    Report

    Report Number
    MW5031082
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 17, 2013
    Report Date
    July 23, 2013
    Manufacturer
    TOSHIBA
    Product Code
    OWB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IMAGING EQUIPMENT IN THE CATH LAB FAILED DURING A PROCEDURE. PT ON THE TABLE AND PROCEDURE IN PROGRESS. JUST BEFORE FINAL IMAGING AND DEPLOYMENT OF CAROTID STENT IMAGING FAILED AND COULD NOT/WOULD NOT RE-BOOT. CASE CANCELED/RESCHEDULED. NO ADVERSE PT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342930 TOSHIBA INFINIX I IMAGING SYSTEM OF ANGIO CATH LAB OWB TOSHIBA DFP-8000D

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other