BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRAVISION DR

    MDR report key: 1250425 · Received November 24, 2008

    Report

    Report Number
    MW5009094
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    November 10, 2008
    Report Date
    November 24, 2008
    Manufacturer
    LIEBEL FLARSHIEM CO.
    Product Code
    MMZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING FLUOROSCOPY ON THE CYSTO BED, THE GENERATOR MADE A VERY LOUD NOISE, THEN QUIT WORKING. DR WAS JUST COMPLETING PUTTING A STENT IN. PATIENT UNDER GENERAL ANESTHESIA AT THE TIME. ROOM WAS SHUT DOWN, NEW GENERATOR INSTALLED FROM COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRAVISION DR UROLOGY BED MMZ LIEBEL FLARSHIEM CO. 700540

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR