BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 1.5T CONVERSION

    MDR report key: 19132155 · Received April 18, 2024

    Report

    Report Number
    3003768277-2024-02295
    Event Type
    Injury
    Date Received
    April 18, 2024
    Date of Event
    January 23, 2024
    Manufacturer
    PHILIPS ELECTRONICS NEDERLAND B.V.
    Product Code
    LNH
    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

    CONCLUSION THERE IS NO INDICATION OF A MALFUNCTION OF THE MR SYSTEM OR COIL USED. THE INJURY, 2ND AND 3RD DEGREE BURNS TO THE THUMB AND THIGH IS CONSISTENT WITH HEATING INCIDENTS CAUSED BY INSUFFICIENT DISTANCE BETWEEN BODY PARTS, A SO-CALLED SKIN-TO-SKIN BURN. CONTRIBUTING FACTORS: THE PATIENT WAS ELDERLY. THE THERMOREGULATION OF THESE PATIENTS IS OFTEN IMPAIRED. THE RISK OF RF ENERGY-RELATED INJURIES IS HIGHER IN PATIENTS WITH IMPAIRED THERMOREGULATION. 19 SCANS WITH HIGH SAR VALUES (> 2 W/KG) WERE EXECUTED IN A SHORT PERIOD OF TIME, ALLOWING NO COOL DOWN TIME FOR THE PATIENT. THE TOTAL ADMINISTERED SPECIFIC ENERGY DOSE OF 18.6KJ/KG IS EXTREMELY HIGH FOR A PATIENT WITH IMPAIRED THERMOREGULATION. THE INSTRUCTIONS FOR USE ADVISES TO AVOID SED >3.0 KJ/KG, PREFERABLY KEEP SED <2.0 KJ/KG FOR THOSE PATIENTS. H3 OTHER TEXT: INCIDENT OCCURRED IN JAN 2024, WAS ONLY RECENTLY REPORTED TO US AND CONSIDERED A USE ERROR. NO INDICATION FOR SYSTEM CONTRIBUTION.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A REPORT THAT A PATIENT RECEIVED 2ND AND 3RD DEGREE BURNS ON THE BACK OF THE FIRST FINGER OF THE LEFT UPPER LIMB AND ON THE EXTERNAL SURFACE OF THE LEFT THIGH OF THE PATIENT. THE PATIENT REQUIRED PLASTIC SURGERY TO TREAT THE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456134 ACHIEVA 1.5T CONVERSION SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH PHILIPS ELECTRONICS NEDERLAND B.V. ACHIEVA 1.5T

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention| O