BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS 62

    MDR report key: 183216 · Received August 6, 1998

    Report

    Report Number
    1217116-1998-00020
    Event Type
    Malfunction
    Date Received
    August 6, 1998
    Date of Event
    July 7, 1998
    Report Date
    July 7, 1998
    Manufacturer
    PHILIPS SYSTEMS MEDEZIN
    Product Code
    IYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE X-RAY TECH HEARD A NOISE COMING FROM THE X-RAY TUBE CARRIAGE SUSPENSION AND THEN ALLEGEDLY THE UNIT DROPPED UNCONTROLLABLY. REPORTEDLY, THE TECH HAD TO PULL THE UNIT UP SHARPLY TO KEEP IT FROM HITTING THE PT. THERE WAS NO INJURY TO THE PT BUT THE TECH REPORTEDLY HAD SORENESS IN HER ARMS BUT NO MEDICAL TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CS 62 DIAGNOSTIC X-RAY TUBE MOUNT IYB PHILIPS SYSTEMS MEDEZIN 9804-182-20102 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN