BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS

    MDR report key: 184840 · Received September 1, 1998

    Report

    Report Number
    MW1014502
    Event Type
    Malfunction
    Date Received
    September 1, 1998
    Date of Event
    August 21, 1998
    Report Date
    September 1, 1998
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CABLE HARNESS TO C-ARM CAUGHT ON GROUNDING POST ON THE BACK OF THE EQUIPMENT CABINET. WHEN OPERATOR ROTATED C-ARM AND TABLE, THE TENSION ON CABLE CAUSED THE SUPPORT ARM TO BE TORN OFF, AND FALL INTO THE PT AREA OF THE TABLE. NO PT WAS ON THIS X-RAY UNIT AT THE TIME OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS X-RAY UNIT-FIXED-C-ARM JAA PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 989600058511 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other 8/21/98.