BEUDAMED
    FDA Adverse Event Other Summary report: N

    HELIODENT MD

    MDR report key: 50633 · Received November 12, 1996

    Report

    Report Number
    8010024-1996-00029
    Event Type
    Other
    Date Received
    November 12, 1996
    Date of Event
    October 11, 1996
    Report Date
    November 9, 1996
    Manufacturer
    SIEMENS PELTON & CRANE
    Product Code
    EAP
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE OPERATOR THAT THE UNIT WOULD CONTINUE TO RADIATE IF THEY HELD THEIR FINGER ON THE EXPOSURE BUTTON. THE UNIT WOULD NOT TIME OUT. FURTHER INVESTIGATION BY A SERVICE TECHNICIAN SHOWED THAT THE UNIT WAS IN FACT RADIATING. THE SERVICE TECHNICIAN CHECKED THE UNIT USING A FLOUROCARD, AND A VOLT METER TO VERIFY EXPOSURE. A TEST WAS ALSO CONDUCTED BY SWITCHING TUBEHEADS WITH A KNOWN OPERATIONAL UNIT AND THE TECHNICIAN GOT THE SAME RESULTS. THERE IS NO MENTION OF RADIATION OF A PT OR INJURIES IN THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELIODENT MD DENTAL INTRORAL X RAY EAP SIEMENS PELTON & CRANE D-3195 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *