BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 1.5T NEW

    MDR report key: 7463992 · Received April 26, 2018

    Report

    Report Number
    3003768277-2018-00032
    Event Type
    Injury
    Date Received
    April 26, 2018
    Date of Event
    April 17, 2018
    Report Date
    April 17, 2018
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K063559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW UP WILL SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    BASED ON THE PROVIDED INFORMATION AND TESTS PERFORMED ON SITE, THERE IS NO INDICATION OF A MALFUNCTION OF THE MRI SYSTEM OR COIL USED THAT CONTRIBUTED TO THE INJURY. THE OBSERVED INJURY IS CONSISTENT WITH INJURIES CAUSED BY CLOSE PROXIMITY TO A CABLE. IN THIS CASE IT COULD HAVE BEEN THE COIL CABLE OR CABLE FROM THE PERIPHERAL (ANESTHESIA INJECTOR) USED. THE PATIENT WAS COVERED BY A BLANKET, WHICH PREVENTED NOTICE BY THE OPERATOR. VARIOUS FACTORS WERE IDENTIFIED THAT CONTRIBUTED TO THE INJURY TO THE PATIENT: - THE PATIENT WAS IN DIRECT CONTACT WITH THE COVER. - THE PATIENT WAS SEDATED. SEDATED / ANESTHETIZED PATIENTS ARE UNABLE TO SENSE OR COMMUNICATE ADVERSE EVENTS. - THE PATIENT WAS OBESE. OBESITY IMPAIRS THE THERMOREGULATION OF THE PATIENT. - THE PATIENT WAS COVERED WITH A BLANKET. THIS HAMPERS THE EFFECT OF VENTILATION. - THE VENTILATION WAS SET AT MEDIUM LEVEL. IN CASE OF HIGH SAR SCANS IT IS ADVISED TO SET THE VENTILATION AT MAXIMUM. - A NUMBER OF HIGH SAR SCANS WERE ADMINISTERED TO THE PATIENT. - THE TOTAL RF ENERGY DOSE ADMINISTERED TO THE PATIENT EXCEEDED THE RECOMMENDED VALUE OF 2 KJ/KG FOR PATIENTS WITH IMPAIRED THERMOREGULATION.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT THAT A PATIENT SUSTAINED A THIRD DEGREE BURN ON THE RIGHT ARM AFTER HAVING HAD AN EXAMINATION ON AN ACHIEVA 1.5T.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308047 ACHIEVA 1.5T NEW SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH PHILIPS HEALTHCARE 781296 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other