BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLANMECA, INC

    MDR report key: 266752 · Received February 22, 2000

    Report

    Report Number
    MW1018326
    Event Type
    Other
    Date Received
    February 22, 2000
    Date of Event
    February 18, 2000
    Report Date
    February 22, 2000
    Manufacturer
    PLANMECA USA, INC.
    Product Code
    EAP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PT OF RECORD REFERRED TO ORAL SURGEON FOR ROUTINE THIRD MOLAR REMOVAL. IN SEPT OF 1998, REPORTER'S PRACTICE PURCHASED A NEW PANORAMIC X-RAY UNIT, PM 2002 CC PROLINE, NUMBER 971996 FOR INSTALLATION IN THEIR NEW OFFICE. MONTHS LATER, REPORTER BECAME AWARE OF A PROBLEM WITH THIS DEVICE. APPARENTLY, WHEN THE FILM CASSETTE IS INSERTED BACKWARDS INTO THE MACHINE, THE MACHINE CONTINUES TO FUNCTION AS IF THE CASSETTE WAS CORRECTLY INSERTED. BACKWARDS CASSETTE INSERTION PRODUCES A RADIOGRAPH WITH THE PT'S LEFT AND RIGHT SIDES REVERSED WHILE THE PRINTING AND MARKINGS REMAIN IN THE USUAL LEFT TO RIGHT FORMAT. REPORTER INVESTIGATED THIS PROBLEM BY COMPARING TWO RADIOGRAPHS TAKEN ON A SINGLE MEMBER, ONE WITH THE FILM CASSETTE LOADED CORRECTLY AND ONE TAKEN WITH A BACKWARDS LOADED CASSETTE. THE ONLY INDICATION THAT THE CASSETTE WAS REVERSED ON LOADING IS A RECTANGLE 1 INCH X 2 7/8 INCHES OF DARKER-THAN-USUAL IMAGE IN THE LOWER RIGHT CORNER. REPORTER WAS UNABLE TO FIND ANY REFERENCE TO ANY INDICATORS OF BACKWARD CASSETTE LOADING IN THE MACHINE'S USER'S MANUAL. THE MANUAL LISTS SEVERAL PAGES OF "ERROR MESSAGES". REPORTER COULD NOT FIND ANY ERROR MESSAGE FOR A BACKWARDS LOADED CASSETTE. FRANKLY, REPORTER IS SURPRISED TO FIND THAT THE MACHINE FUNCTIONED WITH A BACKWARDS LOADED CASSETTE; REPORTER WOULD HAVE ANTICIPATED THAT THE MACHINE WOULD BE DESIGNED SO AS TO FUNCTION ONLY WHEN THE CASSETTE WAS CORRECTLY INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLANMECA, INC PANORAMIC X-RAY UNIT EAP PLANMECA USA, INC. PM2002CC PROLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other