BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHIEVA 1.5T MRI

    MDR report key: 3022811 · Received March 21, 2013

    Report

    Report Number
    MW5029483
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 21, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD MRI DONE AND FOLLOWING PROCEDURE MRI TABLE TOP WITH PT WAS MOVED ONTO TROLLEY. WHILE THE PT WAS MOVED BY TWO ATTENDING STAFF MEMBERS OUT OF THE MRI SUITE, THE TABLE TOP BECAME FREE FROM TROLLEY AND FELL AND STRUCK THE FLOOR. PT WAS STILL SURROUNDED BY PILLOWS AND CUSHIONS AND REMAINED ON TABLE TOP SO NEVER STRUCK THE FLOOR. PHYSICIAN WAS CALLED TO MRI SUITE TO ASSESS THE PT, AND RELEASED PT TO BE RETURNED TO MEDICAL UNIT, AND NOTED NO INJURIES. THE PT WAS PLACED BACK ONTO THE MEDICAL CART OUTSIDE THE ROOM AND RETURNED TO HER UNIT ROOM. THE TABLE TOP APPEARED TO CRACKED ON THE END THAT STRUCK THE FLOOR; SO UNIT WAS PUT OUT OF SERVICE UNTIL PHILIPS REP ARRIVED TO ASSESS THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118504 ACHIEVA 1.5T MRI TABLE TOP LNH PHILIPS MEDICAL SYSTEMS 1.5T
    118505 ACHIEVA 1.5T MRI TROLLEY LNH PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR