BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER CP 80

    MDR report key: 534432 · Received March 17, 2004

    Report

    Report Number
    1217116-2004-00008
    Event Type
    Malfunction
    Date Received
    March 17, 2004
    Date of Event
    February 16, 2004
    Report Date
    February 16, 2004
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE GENERATOR FOR THE HORIZONTAL DIAGNOST H, X-RAY SYSTEM CAUGHT ON FIRE WHICH RELEASED SMOKE. THE FIRE DEPT WAS SUMMONED AND EXTINGUISHED THE FIRE. THE FIRE WAS CONTAINED IN THE GENERATOR SYSTEM. THE NEARBY ROOM SPRINKLER SYSTEMS WERE ACTIVATED DUE TO HEAT AND SMOKE. THE SYSTEM WAS NOT IN PT USE AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER CP 80 X-RAY GENERATOR SYSTEM IZO PHILIPS MEDICAL SYSTEMS 9874-299-10047 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA