BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URO DIAGNOST MRF

    MDR report key: 915251 · Received September 29, 2004

    Report

    Report Number
    1217116-2004-00018
    Event Type
    Malfunction
    Date Received
    September 29, 2004
    Date of Event
    April 2, 2004
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
    Product Code
    IZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED TO DOCUMENT THE MANDATORY CORRECTION OF ONE DEVICE IN THE UNITED STATES. NO INCIDENT WAS REPORTED IN THE UNITED STATES.

    Description of Event or Problem · 1

    OVERHEAD TUBE ARM ON AN X-RAY SYSTEM BROKE LOOSE FROM THE VERTICAL ARM MOST LIKELY DUE TO COLLISION OF THE ARM WITH EXTERNAL EQUIPMENT SUCH AS TROLLEYS, STANDS FOR INFUSION DEVICES OR LAMPS. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URO DIAGNOST MRF X-RAY IZO PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 984950022100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other