BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIEMENS ORTHOPANTOMOGRAPH

    MDR report key: 42937 · Received September 10, 1996

    Report

    Report Number
    8010024-1996-00007
    Event Type
    Other
    Date Received
    September 10, 1996
    Date of Event
    August 5, 1996
    Report Date
    September 5, 1996
    Manufacturer
    PELTON & CRANE
    Product Code
    EAP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE DENTAL PANORAMIC X-RAY EXPOSURE, THE PT MOVED IN SUCH A MANNER AS TO OBSTRUCT THE ROTATION OF THE X-RAY TUBE HEAD. BY PREVENTING THE FREE ROTATION OF THE UNIT THE PT CAUSED RADIATION EXPOSURE IN ONE AREA FOR A LONGER THAN EXPECTED DURATION. AFTER A COUPLE OF SECONDS THE OPERATOL SAW WHAT HAD HAPPENED AND DISCONTINUED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS ORTHOPANTOMOGRAPH INTRA ORAL X-RAY EAP PELTON & CRANE OP5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other