BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIA

    MDR report key: 23369382 · Received October 23, 2025

    Report

    Report Number
    3003768277-2025-012996
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    September 5, 2025
    Report Date
    October 23, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LNH
    UDI-DI
    00884838095076
    PMA / PMN Number
    K063559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER OUR INVESTIGATION AND ANALYSIS, IT WAS CONCLUDED THAT THE MR SYSTEM AND COIL USED IN THIS CASE WERE WORKING CORRECTLY. THERE WAS NO INDICATION OF A MALFUNCTION WHICH WOULD HAVE CONTRIBUTED TO THE INCIDENT. BASED ON THE AVAILABLE INFORMATION, IT CANNOT BE DETERMINED IF THE PATIENT WAS HARMED DURING THE MRI SCAN OR PRIOR TO THE SCAN. THE RF BURN AT THE TOES OF THE INFANT MIGHT HAVE BEEN CAUSED DUE TO CONTACT OR BEING IN CLOSE PROXIMITY TO THE COIL CABLE OR THE OTHER DEVICES (PPU, EKG, TENSIOMETER) USED DURING THE SCAN. ALTHOUGH, THE PULSE OXIMETER (PPU - PERIPHERAL PULSE UNIT) WAS NOT PLACED ON THE SAME FOOT WHERE THE INJURIES WERE, THE PATIENT HEATING QUESTIONNAIRE INDICATES THAT PPU SENSOR WAS CLOSE TO THE AFFECTED AREA, AND OTHER PERIPHERAL OBJECTS SUCH AS EGK AND TENSIOMETER. THE PPU SENSOR CLAMPS ON THE PATIENTS FOOT AND CAN BE PLACED AT DIFFERENT POSITIONS. ADDITIONALLY, SINCE THE PATIENT HAD PRE-EXISTING WOUNDS PRIOR TO THE MRI EXAMINATION, IT IS NOT POSSIBLE TO CONCLUSIVELY IDENTIFY OTHER POTENTIAL CONTRIBUTING FACTORS TO THE INJURIES THAT MAY HAVE OCCURRED BEFORE THE SCAN. CONTRIBUTING FACTORS TO THIS INCIDENT ARE AS FOLLOWS: 1 SCAN WITH HIGH SAR VALUES (>2 W/KG, AT 2.4 W/KG) WAS EXECUTED. HIGH SAR SCANS ARE A BIGGER CHALLENGE FOR THE COOL DOWN MECHANISM THAN LOW SAR SCANS. THE PATIENT WAS SEDATED OR ANESTHETIZED. THE THERMOREGULATION OF SEDATED PATIENTS IS KNOWN TO BE IMPAIRED. THE RISK OF RF ENERGY-RELATED INJURIES IS HIGHER IN PATIENTS WITH IMPAIRED THERMOREGULATION.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A REPORT THAT THE 6-MONTH-OLD BABY PATIENT EXPERIENCED A BURN ON THE LEFT FOOT. THE EXAM WAS CONDUCTED ON THE EQUIPMENT ON (B)(6) 2025. THE HOSPITAL REPORTED TO THE MRI DEPARTMENT, FOUR DAYS AFTER EXAM, THAT THE PATIENT HAD BEEN BURNED IN THE MRI. AT THE TIME OF THE EXAM, THE MRI TECH NOTED THE PATIENT ALREADY HAD THE WOUNDS ON HIS LEFT FOOT PRIOR TO THE MRI BEING PERFORMED. A DIGITAL PHOTO WAS PROVIDED WHICH SHOWS THE REPORTED INJURY TO THE LEFT FOOT. ON THE POSTERIOR SIDE OF THE GREAT TOE AND TOE NEXT TO IT THERE ARE CIRCULAR REDDENED AREAS WHICH APPEAR TO BE THROUGH THE SUPERFICIAL LAYER OF SKIN. ON THE BABY/SMALL TOE, THERE IS A SMALLER REDDENED AREA WHICH ALSO APPEARS TO BE THROUGH THE INITIAL LAYERS OF SKIN. THE PATIENT UNDERWENT A BRAIN MRI IN THE HEADFIRST, SUPINE POSITION. IT IS REPORTED THE PATIENT WAS SEDATED OR ANESTHETIZED. THERE WAS NO TREATMENT PERFORMED IN THE MRI SUITE TO THE REPORTED WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544884 INGENIA FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET LNH PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. SMARTPATH TO DSTREAM FOR 1.5T 00884838095076

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Male Other