BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERI-PRO

    MDR report key: 1426539 · Received April 8, 2009

    Report

    Report Number
    2428225-2009-00001
    Event Type
    Malfunction
    Date Received
    April 8, 2009
    Date of Event
    March 8, 2009
    Report Date
    April 7, 2009
    Manufacturer
    AIR TECHNIQUES INC
    Product Code
    IXW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MDR INVESTIGATION RESULTS: THE COMPLAINTS WERE REVIEWED FOR THE PERI PRO I DEVICE SINCE INITIAL MANUFACTURING DATE. NO INCIDENCES WERE REPORTED FOR THIS PRODUCT. THIS DEVICE WAS FOUND TO HAVE NEVER BEEN SERVICED BY AIR TECHNIQUES. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND TO BE COMPLETE AND THE DEVICE WAS DETERMINED TO MEET ENGINEERING DESIGN REQUIREMENT SPECIFICATIONS. IT APPEARS THAT THE CAUSE OF THE INCIDENT WAS THAT THE DEVICE WAS SERVICED BY AN UNAUTHORIZED REPRESENTATIVE.

    Description of Event or Problem · 1

    IN 2009, A COMPLAINT WAS RECEIVED REGARDING A FILM PROCESSOR WHICH CAUGHT FIRE DURING OPERATION AT A USER FACILITY. THE USER FACILITY STATED THAT THE NURSE WHO WITNESSED THE INCIDENT CLAIMED THERE WAS NO INJURY TO ANY INDIVIDUAL, STAFF, OR PATIENT. A MONTH LATER, THE USER FACILITY REFUSED TO DIVULGE THE PATIENT OR WITNESS INVOLVED WITH THIS EVENT IN SPITE OF SEVERAL ATTEMPTS TO OBTAIN THIS INFORMATION. THE USER FACILITY STATED THAT THEY SHOULD NOT HAVE TO PROVIDE THIS INFORMATION SINCE NO ONE WAS INJURED. THE USER FACILITY ALSO REFUSED TO PROVIDE US WITH THE SERVICE HISTORY OF THE DEVICE. ON 04/07/09, WE WERE ADVISED BY AN EMPLOYEE AT THE USER FACILITY THAT THE DEVICE WAS IN STORAGE FOR AN UNKNOWN LENGTH OF TIME. THE DEVICE WAS BROUGHT OUT OF STORAGE AND USED FOR APPROXIMATELY ONE DAY BEFORE THE INCIDENT OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other