BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 3.0T TX

    MDR report key: 24401452 · Received February 20, 2026

    Report

    Report Number
    3003768277-2026-100822
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    January 22, 2026
    Report Date
    April 9, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LNH
    UDI-DI
    884838004139
    PMA / PMN Number
    K063559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT UNDERWENT A PROSTATE MR SCAN IN THE FEET FIRST SUPINE POSITION. A SENSE XL TORSO COIL 3.0T WAS USED. THE PATIENT HAD PASSIVE IMPLANTS AND IS DESCRIBED AS ELDERLY. DUE TO THE HIP IMPLANTS, THE EXAMINATION TOOK LONGER. SKIN REDDENING, HEATING SENSATION AND BLISTERING WAS REPORTED ON THE LOWER LEFT FOREARM. THE ARMS WERE POSITIONED AT CHEST LEVEL. THE CUSTOMER INDICATED THAT THE COIL CABLE WAS WRAPPED IN A TOWEL SO THAT THE ARM HAD NO DIRECT CONTACT WITH THE COIL CABLE. IN ADDITION, PADDING WAS USED TO PREVENT SKIN-SKIN AND SKIN-CABLE CONTACT. IN THE PATIENT HEATING QUESTIONNAIRE (PHQ), THE CUSTOMER INDICATES THAT THE PATIENT MAY HAVE POTENTIALLY BEEN IN CONTACT WITH THE BORE WALL. IN ADDITION, THE PHQ STATES THAT NO PADDING WAS USED TO PREVENT BODY TO BORE CONTACT. AFTER OUR INVESTIGATION AND ANALYSIS, IT WAS CONCLUDED THAT THERE IS NO INDICATION OF A SYSTEM OR COIL MALFUNCTION THAT COULD HAVE CONTRIBUTED TO THE INCIDENT. IT WAS CONCLUDED THAT BASED ON THE INJURY AREA AND NATURE OF THE INJURY, THE LIKELY CAUSE WAS DIRECT OR NEAR CONTACT BETWEEN THE PATIENTS ARM AND THE BORE WALL. IT WAS MENTIONED THAT NO PADDING WAS USED TO PREVENT THIS FROM OCCURRING AND THAT CONTACT WAS LIKELY TO HAVE OCCURRED. CONTRIBUTING FACTORS: THE THERMOREGULATION OF ELDERLY PATIENTS IS KNOWN TO BE IMPAIRED. THE RISK OF RF ENERGY-RELATED INJURIES IS HIGHER IN PATIENTS WITH IMPAIRED THERMOREGULATION. THE VENTILATION WAS ON LEVEL 3. LEVEL 5 IS RECOMMENDED FOR PATIENTS WITH IMPAIRED THERMOREGULATION.

    Additional Manufacturer Narrative · 0

    PHILIPS HAS STARTED AN INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A REPORT THAT THE PATIENT UNDERWENT A PROSTATE MR SCAN IN THE FEET FIRST SUPINE POSITION. THE PATIENT HAD PASSIVE IMPLANTS AND IS DESCRIBED AS ELDERLY. DUE TO THE HIP IMPLANTS, THE EXAMINATION TOOK LONGER. SKIN REDDENING, HEATING SENSATION AND BLISTERING WAS REPORTED ON THE LEFT FOREARM. ON THE DAY OF THE INCIDENT, A FIRST-DEGREE BURN OCCURRED. IT IS UNKNOWN HOW IT DEVELOPED FURTHER. A COOL PACK WAS APPLIED. IT IS REPORTED THE BURN IS EXPECTED TO HEAL COMPLETELY. THE SIZE OF THE BLISTER IS DOCUMENTED AS UNKNOWN. DUE TO THE UNKNOWN BLISTER SIZE, UNABLE TO DETERMINE THE SEVERITY OF THE REPORTED BURN. ADDITIONAL INFORMATION IS REQUIRED TO ASSESS THE SEVERITY OF THE REPORTED ISSUE. AS THERE IS INSUFFICIENT INFORMATION WITHIN THE EVENT DESCRIPTION, WE ARE UNABLE TO RULE OUT SERIOUS INJURY AND THEREFORE OUT OF PRECAUTION, WE DECIDED TO REPORT THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460183 ACHIEVA 3.0T TX FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET LNH PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ACHIEVA 3.0T 884838004139

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other