BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 1.5T NEW

    MDR report key: 25253302 · Received May 22, 2026

    Report

    Report Number
    3042177665-2026-000084
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 22, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LNH
    UDI-DI
    884838004108
    PMA / PMN Number
    K063559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 IS NO INDICATION OF A MALFUNCTION OF THE MR SYSTEM OR COIL USED THAT COULD HAVE CONTRIBUTED TO THE INCIDENT. THE PATIENT HEATING QUESTIONNAIRE WAS REVIEWED, WHERE THE CUSTOMER INDICATES THAT NO PADDING WAS USED TO PREVENT SKIN-SKIN CONTACT. THE CUSTOMER DOES INDICATE THAT THE "OPERATOR REPORTED SHE PUT AN ENROLLED SHEET BETWEEN LEGS". AN ENROLLED SHEET OF (UNKNOWN) MATERIAL (E.G., PAPER OR FABRIC) IS NOT APPROPRIATE PADDING TO BE USED IN MR PROCEDURES, FOR REASONS OUTLINED BELOW: MRI USES RADIOFREQUENCY (RF) ENERGY. WHEN PARTS OF THE BODY TOUCH EACH OTHER (SKIN-TO-SKIN) OR TOUCH CONDUCTIVE MATERIALS, CURRENTS CAN CONCENTRATE AT CONTACT POINTS AND CAUSE LOCAL HEATING AND BURNS. A SHEET IS THIN, MAY COMPRESS OR SHIFT, AND CAN ALLOW SKIN-TO-SKIN CONTACT OR CREATE SMALL FOLDS THAT CONCENTRATE PRESSURE AND HEAT. IT IS NOT DESIGNED TO MAINTAIN SEPARATION UNDER COMPRESSION OR TO AVOID CREATING INADVERTENT CONDUCTIVE LOOPS. MRI-SAFE PADDING PROVIDED BY PHILIPS ARE DESIGNED TO KEEP CONSISTENT SEPARATION, RESIST COMPRESSION, AND NOT INTRODUCE CONDUCTIVE MATERIALS. THEREFORE, IT WAS CONCLUDED, THAT EXCESSIVE LOCAL SAR DUE TO SKIN-SKIN CONTACT (RELATIVE POSITION OF PATIENT BODY PARTS IS SUCH THAT UNINTENDED RF COUPLING IS CREATED) CAUSED THIS INJURY. CONTRIBUTING FACTORS TO THIS EVENT ARE AS FOLLOWS: THE PATIENT WAS OBESE. THE THERMOREGULATION OF OBESE PATIENTS IS KNOWN TO BE IMPAIRED. THE RISK OF RF ENERGY-RELATED INJURIES IS HIGHER IN PATIENTS WITH IMPAIRED THERMOREGULATION. THE TOTAL ADMINISTERED SPECIFIC ENERGY DOSE OF 3.266 KJ/KG EXCEEDED THE RECOMMENDED LIMIT OF 2.0 KJ/KG FOR PATIENTS WITH IMPAIRED THERMOREGULATION.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A REPORT THAT THE PATIENT EXPERIENCED A SECOND DEGREE BURN AFTER PELVIS EXAMINATION, THE APPROXIMATE SIZE OF THE BLISTER IS REPORTED AS 5CM X 1 CM CYLINDRICAL SHAPE. NO INFORMATION WAS PROVIDED ABOUT MEDICAL INTERVENTION. A DIGITAL PHOTO WAS RECEIVED AND DEPICTS A FLUID FILLED BLISTER MATCHING THE DESCRIPTION PROVIDED. THE BLISTERING WAS NOTED IN BETWEEN THE PATIENT'S THIGHS. NO INFORMATION WAS PROVIDED ABOUT MEDICAL INTERVENTION. IT IS EXPECTED THE INJURY WILL HEAL COMPLETELY. DUE TO THE SIZE OF THE REPORTED BLISTER, THE REPORTED INJURY MEETS THE CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611927 ACHIEVA 1.5T NEW FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET LNH PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ACHIEVA 1.5T 884838004108

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male Other