BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILIPS ACHIEVA 1.5T MRISCANNER/8CHANNEL BRAIN COIL

    MDR report key: 3099475 · Received May 2, 2013

    Report

    Report Number
    MW5030060
    Event Type
    Other
    Date Received
    May 2, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    PHILIPS
    Product Code
    LNH
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT MRI OF BRAIN ON (B)(6) 2013, WITHOUT INCIDENT. ON (B)(6) 2013, PT RETURNED TO FACILITY COMPLAINING OF A CIRCLE BURN ON HER CHIN. PT STATED IT APPEARED ON (B)(6) 2013, OFFERED TO SEND THE PT TO HER PHYSICIAN FOR TREATMENT WHICH SHE REFUSED. PHILIPS SERVICE ENGINEERS WERE CONTACTED AFTER PT LEFT AND INSTRUCTED TO EVALUATE EQUIPMENT OF ANY MALFUNCTIONS. RESONANCE TECHNOLOGY INC MFR OF MRI CINEVISION A/V SYSTEM WAS ALSO NOTIFIED OF EVENT AND ASKED TO INSPECT THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192408 PHILIPS ACHIEVA 1.5T MRISCANNER/8CHANNEL BRAIN COIL MRI LNH PHILIPS
    192481 PHILIPS CINEMAVISION - MRI A/V SYSTEM MRI LNH RESONANCE TECHNOLOGY, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other