BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERI-PRO

    MDR report key: 1327706 · Received February 26, 2009

    Report

    Report Number
    1327706
    Event Type
    Malfunction
    Date Received
    February 26, 2009
    Date of Event
    February 6, 2009
    Report Date
    February 26, 2009
    Manufacturer
    AIR TECHNIQUES, INC.
    Product Code
    EGY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    X-RAY FILM DEVELOPER WAS IN USE WHEN STAFF NOTICED THICK BLACK SMOKE COMING OUT OF THE TOP VENT AREA OF DEVELOPER. THE ELECTRICAL PLUG WAS IMMEDIATELY REMOVED FROM THE WALL. RIGHT AFTER THAT FLAMES BURST OUT OF THE MACHINE. THE FLAMES REACHED ABOUT A FOOT AND A HALF HIGH. STAFF USED A BLANKET AND A FIRE EXTINGUISHER TO PUT OUT THE FIRE. STAFF INVOLVED COMPLAINED OF SOME MINOR IRRITATION FROM BREATHING THE SMOKE.LATER ANALYSIS OF THE DEVICE REVEALED THE FAN HAD FAILED AND THE THERMAL SAFETY FUSE WAS IMPROPERLY WIRED IN A WAY THAT BYPASSED IT. THE MISWIRING IS MOST LIKELY A RESULT OF AN IMPROPER REPAIR DONE BY THE HOSPITAL AT SOME TIME IN THE PAST. THE DESIGN OF THE DEVICE MAKES MISWIRING A FAIRLY EASY MISTAKE AS THERE ARE MANY INTERCHANGEABLE CONNECTION POINTS. EVEN IF THE THERMAL SAFETY FUSE IS INTACT, THERE IS THE POSSIBILITY FOR PIECES OF FILM TO FALL DIRECTLY ONTO THE HEATING ELEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERI-PRO FILM PROCESSOR, DENTAL X-RAY EGY AIR TECHNIQUES, INC. 90000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES| NO OTHER THERAPIES