BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 3.0 T

    MDR report key: 4726026 · Received April 22, 2015

    Report

    Report Number
    3003768277-2015-00032
    Event Type
    Injury
    Date Received
    April 22, 2015
    Date of Event
    March 15, 2015
    Report Date
    March 26, 2015
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K043147
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THERE WAS A MISUNDERSTANDING OF INFORMATION REQUESTED. ALTHOUGH INITIALLY IT WAS INDICATED THAT NO PATIENT VENTILATION WAS SET, IT TURNED OUT THAT THE PATIENT VENTILATION WAS SET AT MEDIUM LEVEL AND IS THEREFORE NO LONGER CONSIDERED TO BE A CONTRIBUTING CAUSE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE PROVIDED INFORMATION AND INVESTIGATION PERFORMED NO MALFUNCTION OF THE MR DEVICE OR COIL USED WAS OBSERVED THAT CONTRIBUTED TO THE INJURY. THE REPORTED CORNEA DAMAGE WAS EVALUATED. THE POST MARKET DATA WAS EVALUATED FOR OTHER SIMILAR INJURIES. THERE WERE NO OTHER CASES REPORTED. NO CAUSE OF THE REPORTED INJURY COULD BE ESTABLISHED. ALTHOUGH NO CAUSE COULD BE ESTABLISHED, THE PROVIDED INFORMATION DOES REVEAL SOME CONTRIBUTING FACTORS FOR MR RELATED HEATING SENSATIONS. THE OBSERVED CONTRIBUTING FACTORS ARE: PATIENT VENTILATION WAS NOT SET. (ADEQUATE PATIENT VENTILATION PROMOTES PATIENT COMFORT.) PATIENT¿S CLOTHING. THE HOSPITAL PROVIDED CLOTHING IS REPORTED TO BE MADE OF POLYPROPYLENE. POLYPROPYLENE IS AN INSULATOR, IT RETAINS HEAT AND HINDERS THE HEAT DISSIPATION. WHOLE BODY RF DOSE OF 1.9 KJ/KG WHICH IS ONLY SLIGHTLY LOWER THAN THE ADVISED LIMIT OF 2 KJ/KG FOR PATIENTS WITH AN IMPAIRED THERMOREGULATION.

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    PHILIPS HAS RECEIVED A REPORT THAT A PT SUFFERED SWELLING IN THE FACE AND ON THE LEFT SIDE OF HER BODY AFTER AN MRI EXAMINATION. FURTHERMORE SHE REPORTED THAT SHE SUSTAINED CORNEA DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267627 ACHIEVA 3.0 T SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH PHILIPS HEALTHCARE 781177

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other