BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 1141647 · Received August 28, 2008

    Report

    Report Number
    MW5008120
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 28, 2008
    Manufacturer
    UNKNOWN
    Product Code
    LNH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT A 4:45 P.M. APPOINTMENT FOR A RIGHT-HIP MRI, THE PT WAS PLACED IN THE MRI SCANNER AND THE SCAN COMMENCED. APPROX 10 MINUTES LATER, THE TECHNICIAN ABORTED THE SCAN, TELLING THE PT, "THE SCANNER WAS ACTING UP AND THE REPAIR GUY CAME YESTERDAY. WE'RE HAVING A PROBLEM WITH RADIOFREQUENCY INTERFERENCE. I GUESS IT'S NOT WORKING YET." THE PT WAS TOLD TO RESCHEDULE HER APPOINTMENT FOR ANOTHER TIME. THE PT HAS CONCERNS ABOUT THE POSSIBLE NEGATIVE IMPACT OF BEING IN THE MRI SCANNER FOR SO LONG WITH "RADIOFREQUENCY" INTERFERENCE AND WHATEVER THAT MAY MEAN TO THE PT'S HEALTH. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: RIGHT HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MRI SCANNER LNH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR