BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIA 1.5T

    MDR report key: 20012445 · Received August 21, 2024

    Report

    Report Number
    3003768277-2024-04554
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    June 3, 2024
    Report Date
    August 20, 2024
    Manufacturer
    PHILIPS ELECTRONICS NEDERLAND B.V.
    Product Code
    LNH
    UDI-DI
    00884838055322
    PMA / PMN Number
    K163116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 COILS USED THAT COULD HAVE CONTRIBUTED TO THE INCIDENT. THE INJURY, A LARGE 2ND DEGREE BURN TO THE LEFT SIDE OF THE CHEST CAN BE EXPLAINED BY INSUFFICIENT DISTANCE BETWEEN BODY PARTS, A SO-CALLED SKIN-TO-SKIN BURN BETWEEN HER LEFT CHEST AND LEFT UPPER ARM. CONTRIBUTING FACTORS: 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 THERMOREGULATION OF PATIENTS WHO ARE HYPERTENSIVE IS OFTEN IMPAIRED. THE RISK OF RF ENERGY-RELATED INJURIES IS HIGHER IN PATIENTS WITH IMPAIRED THERMOREGULATION. THE TOTAL ADMINISTERED SPECIFIC ENERGY DOSE OF 4.3 KJ/KG IS VERY 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. THE VENTILATION WAS ON LEVEL 3. LEVEL 5 IS RECOMMENDED, IT SUPPORTS THE COOL DOWN MECHANISM.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A REPORT THROUGH THE MEDWATCH SYSTEM THAT A PATIENT SUFFERED A LARGE 2ND DEGREE BURN TO THE LEFT SIDE OF THE CHEST DURING A NECK AND SPINE EXAMINATION. THE PATIENT REQUIRED TREATMENT AS A RESULT OF THIS INJURY SUSTAINED. THE CUSTOMER DID NOT REPORT THIS INCIDENT THROUGH OUR REGULAR SERVICE CHANNELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153513 INGENIA 1.5T SYSTEM, NUCLEAR MAGNETIC IMAGING LNH PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 1.5T R5 BASED 00884838055322

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention| O