BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENUITY TF PET/MR

    MDR report key: 3597167 · Received January 16, 2014

    Report

    Report Number
    1525965-2014-00014
    Event Type
    Injury
    Date Received
    January 16, 2014
    Report Date
    January 7, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    OUO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A F/U MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A TEST OF AN MRI BREAST PROTOCOL WITH THE NEW MAMMOCOIL ON THE PHILIPS PET/MRI, A PT WAS POSITIONED ON THE COIL AND THE TABLE WAS MOVED INTO THE MRI TUNNEL USING THE "TRAVEL TO SCANPLANE" BUTTON. DURING THE MOVEMENT OF THE TABLE TO THE SCANNING POSITION, THE PT BECAME TRAPPED BETWEEN THE COIL AND THE TOP OF THE BORE. THE PT INDICATED PAIN AND WAS IMMEDIATELY REMOVED FROM THE BORE. A FEW DAYS LATER, THE PT WAS DIAGNOSED WITH A BROKEN RIB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43832 INGENUITY TF PET/MR OUO PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 882380 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1