BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSE XL TORSO COIL, 1.5T MK2

    MDR report key: 21750751 · Received April 2, 2025

    Report

    Report Number
    1051786-2025-000005
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    December 24, 2022
    Report Date
    May 30, 2025
    Manufacturer
    PHILIPS ELECTRONICS NEDERLAND B.V.
    Product Code
    MOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS STARTED AN INVESTIGATION INTO THIS ALLEGED EVENT. INITIAL FINDINGS: THERE IS NO RECORD OF A PHILIPS MRI MACHINE INSTALLED AT THE SITE MENTIONED BY THE PATIENT. THERE IS ALSO NO RECORD OF A XL TORSO COIL LINKED TO THE SITE MENTIONED BY THE PATIENT.

    Additional Manufacturer Narrative · 0

    PHILIPS HAS PERFORMED AN INVESTIGATION INTO THIS ALLEGED INCIDENT. IT WAS CONCLUDED THAT NO PHILIPS MR SYSTEM NOR AN XL TORSO WAS INSTALLED AT THIS SITE AT ANY MOMENT. THE CUSTOMER CONFIRMED VERBALLY THAT THEY ARE USING NO PHILIPS MR SYSTEMS BUT MR SYSTEMS PROVIDED BY GE HEALTHCARE.

    Description of Event or Problem · 0

    PHILIPS RECEIVED REPORT FROM A PATIENT WHO CLAIMED TO HAVE RECEIVED A BURN DURING AN MR EXAMINATION. THIS INJURY EXACERBATED OVER TIME EVENTUALLY LEADING TO AMPUTATION OF THE TOP OF THE 2ND FINGER ON THE RIGHT HAND. THE PATIENT INDICATES THAT THIS IS LINE TO THE KNOWN ISSUE OF THE XL TORSO COIL KNOWN TO THE FDA UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2324802 SENSE XL TORSO COIL, 1.5T MK2 SENSE XL TORSO COIL, 1.5T MK2 MOS PHILIPS ELECTRONICS NEDERLAND B.V. 453567502284

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention