BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS

    MDR report key: 670569 · Received December 30, 2005

    Report

    Report Number
    670569
    Event Type
    Malfunction
    Date Received
    December 30, 2005
    Date of Event
    April 21, 2005
    Report Date
    December 30, 2005
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN INTERVENTIONAL PROCEDURE FLUOROSCOPY UNIT'S COMPUTER FROZE AND HAD TO BE REBOOTED. DURING THIS TIME THE PATIENT HAD TO WAIT WITH AN INTERVASCULAR SHEATH IN HIS INTERNAL JUGULAR VEIN FOR APPROXIMATELY FIVE MINUTES WHILE THE UNIT HAD TO BE REBOOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS FLUOROSCOPY UNIT JAA PHILIPS MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR