BEUDAMED
    FDA Adverse Event Other Summary report: N

    GYROSCAN ACS-NT

    MDR report key: 387338 · Received April 8, 2002

    Report

    Report Number
    1217116-2002-00003
    Event Type
    Other
    Date Received
    April 8, 2002
    Date of Event
    March 5, 2002
    Report Date
    April 4, 2002
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA
    Product Code
    LNH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED L-SPINE MRI WITH SYNERGY SPINE COIL IN 2002 AT 10:00AM. PT WORE EAR-MUFF STYLE HEAD PHONES FOR NOISE SUPPRESSION AND MUSIC. LATER THAT DAY PT CALLED THE SITE REPORTING THAT A BURN WAS DEVELOPING IN FRONT OF THEIR LEFT EAR FROM THE SIDEBURN TO THE EDGE OF THEIR JAW. THE PT HAD NOTED SOME WARMTH IN THAT AREA DURING THE SCAN, BUT THE BURN (2ND DEGREE) DIDN'T APPEAR UNTIL MUCH LATER WHEN BLISTERING APPEARED. THE SITE IMMEDIATELY STOPPED USING THE HEADPHONES AND CALLED THEIR SALESMAN. NO PROBLEMS WERE REPORTED DURING THE SCANS AND THE IMAGES APPEARED NORMAL. DISPOSABLE COVERS WERE USED WITH THE HEAD PHONES AND NO EAR JEWELRY WAS REPORTED BY THE SITE. NO PROBLEMS WERE SEEN DURING THE BDAS AUTOMATIC MAXKW, PMU, POWER REFERENCE AND PICKUP COIL CALIBRATIONS.

    Description of Event or Problem · 1

    SINCE THE PATIENT WAS BUMPED BURNED NEAR THE EAR THE HEADPHONES, IN USE BY PHILIPS SINCE 1994, WERE EXAMINED AND TESTED AS FOLLOWS: (1) X-RAYED FOR METAL PARTS (HEAT PRODUCING) - NONE FOUND, (2) PHYSICAL DAMAGE TO HEADPHONES FROM HEAT - NO VISUALE DEVIATIONS FROM THE STANDARD PRODUCT FOUND, (3) TESTED FOR POSSIBLE RF TUNING INTERFERENCE - NO INTERFERENCE OBSERVED. ALSO, NO VISUAL DEVIATIONS FROM THE STANDARD HEADPHONE PRODUCT WAS OBSERVED. NEXT HEADPHONE PROTECTION TISSUES WORN BY THE PATIENT WERE TESTED AND FOUND TO BE METAL FREE. THE HEADPHONES FIT PROPERLY ON THE PATIENT WITHOUT ABNORMAL PRESSURE TO THE HEAD. THE PATIENT HAD NO MEDICAL HISTORY NOR WORE METAL PARTS (JEWELRY) CLOSE TO PT'S EARS. NO ABNORMAL PERSPIRING OF THE PATIENT WAS OBSERVED WHICH IF PRESENT MIGHT HAVE CREATED A RF LOOP AND HEAT. NO DEGRADTION OF THE IMAGE QUALITY OF THE ACQUIRED DATA DURING THE SCANS WAS OBSERVED. THE SYSTEM WAS TUNED BY THE SERVICE ENGINEER AND NO PROBLEMS WERE FOUND. THEREFORE, IN CONCLUSION NO FAILURE WAS DETECTED AND PRODUCT IS WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYROSCAN ACS-NT MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH PHILIPS MEDICAL SYSTEMS NORTH AMERICA MMR 1481 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other