BEUDAMED
    FDA Adverse Event Other Summary report: N

    GRYOSCAN ACS-NT

    MDR report key: 387308 · Received April 8, 2002

    Report

    Report Number
    1217116-2002-00004
    Event Type
    Other
    Date Received
    April 8, 2002
    Date of Event
    March 5, 2002
    Report Date
    April 1, 2002
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUPPLEMENTAL REPORT: 1217116-2002-0003 INFO: THIS REPORT IS TO PROVIDE THE FINAL INVESTIGATION OBSERVATIONS AND CONCLUSION THAT WAS STILL IN PROCESS WHEN FILING THIS MDR. THE REPORT IS AS FOLLOWS: SINCE THE PT WAS 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 VISUAL 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 PT WERE TESTED AND FOUND TO BE METAL FREE. THE HEADPHONES FIT PROPERLY ON THE PT WITHOUT ABNORMAL PRESSURE TO THE HEAD. THE PT HAD NO MEDICAL HISTORY NOR WORE METAL PARTS (JEWELRY) CLOSE TO HIS EARS. NO ABNORMAL PERSPIRING OF THE PT WAS OBSERVED WHICH IF PRESENT MIGHT HAVE CREATED A RF LOOP AND HEAT. NO DEGRADATION OF THE IMAGE QUALITY OF THE ACQUIRED DATA DURING THE SCANS WAS OBSERVED. THE SYSTEM WAS TUNED BY THE SERFICE ENGINEER AND NO PROBLEMS WERE FOUND. THEREFORE, IN CONCLUSION NO FAILURE WAS DETECTED AND PRODUCT IS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    PT RECEIVED MRI SCAN OF THE ANKLE USING THE QUAD KNEE COIL FOOT FIRST INTO THE MAGNET. THE PT'S HEAD REMAINED OUTSIDE THE MAGNET BORE FOR THE ENTIRE SCAN. THE PT USED THE EARMUFF STYLE HEAD-PHONE FOR NOISE SUPPRESSION AND MUSIC. DISPOSABLE COVERS ARE USED ON THE HEAD-PHONE SETS. THE PT REPORTED LATE THE NEXT DAY THAT THE EDGE OF THEIR RIGHT EAR WAS RED AND SORE (2ND DEGREE BURNS). 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.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other