BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO COLLIMATOR

    MDR report key: 115501 · Received August 21, 1997

    Report

    Report Number
    1217116-1997-00027
    Event Type
    Malfunction
    Date Received
    August 21, 1997
    Date of Event
    June 24, 1997
    Report Date
    June 24, 1997
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    KPW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE PT WAS LAYING ON THE TABLE DURING AN ENEMA PROCEDURE AND AS THE TECHNOLOGIST MOVED THE OVERHEAD X-RAY TUBE ASSEMBLY, A COVER ON THE COLLIMATOR FELL OFF AND ALLEGEDLY STRUCK THE PT ON THE BACK OF THE HEAD. THE PT REPORTEDLY HAD A SMALL LACERATION AND SMALL BUMP ON HER HEAD. SHE WAS EXAMINED AND THE CUT WAS CLEANED AND TREATED WITH PEROXIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO COLLIMATOR BEAM LIMITING DEVICE KPW PHILIPS MEDICAL SYSTEMS 9804-602-82403 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other