BEUDAMED
    FDA Adverse Event Other Summary report: N

    CERETOM

    MDR report key: 812460 · Received January 24, 2007

    Report

    Report Number
    3004938766-2007-00001
    Event Type
    Other
    Date Received
    January 24, 2007
    Date of Event
    December 22, 2006
    Report Date
    January 23, 2007
    Manufacturer
    NEUROLOGICA CORPORATION
    Product Code
    JAK
    PMA / PMN Number
    K051765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL TEST BY NEUROLOGICA ENGINEER SHOWED UNIT WAS FUNCTIONING PROPERLY. THE INITIAL VIEWING OF THE IMAGES SHOWED WHAT APPEARED TO BE AN ARTIFACT CAUSED BY THE IMPROPER POSITIONING OF THE PATIENT'S HEAD IN THE SCANNER AND A METALLIC OBJECT IMPLEMENTED LESS THAN 5 MM FROM THE IMAGE PLAN. THE PATIENT'S HEAD WAS POSITIONED INCORRECTLY (NOT CENTERED, ANGLED) ACCORDING TO THE CERETOM USER MANUAL AND TRAINING PREVIOUSLY PROVIDED BY NEUROLOGICA. IT IS WELL KNOW IN CT IMAGING THAT HEAD SCANS PERFORMED OFF-CENTER CAN PRODUCE ARTIFACTS. AN IMPLANTED METAL ARTIFACT IS KNOWN IN CT IMAGING TO AFFECT THE CT-VALUE IN THE VICINITY OF THE IMPLANT. THE EFFECT DEPENDS ON THE LOCATION, SIZE AND DENSITY OF THE METAL OBJECT. FOLLOW-UP: THERE WAS NO PATIENT INJURY TO REPORT. THE HOSPITAL AND TECHNICIAN WERE REINSTRUCTED BY NEUROLOGICA TO POSITION PATIENTS ACCORDING TO INSTRUCTIONS IN THE USER MANUAL A TYPICAL CERETOM PATIENT SCAN COVERS THE DISTANCE FROM THE NOSE TO THE TOP OF THE SKULL, APPROXIMATELY 16 CM. THE INITIAL VIEWING OF THE IMAGES SHOWED WHAT APPEARED TO BE AN ARTIFACT CAUSED BY THE IMPROPER POSITIONING OF THE PATIENT'S HEAD IN THE SCANNER AND A METALLIC OBJECT IMPLEMENTED LESS THAN 5 MM FROM THE IMAGE PLAN. IN GENERAL, IN A FIXED SCANNER, THE PATIENT'S HEAD POSITION IS RESTRAINED BY THE SCANNER TABLE AND A HEAD HOLDER. HOWEVER, POSITIONING OF A PATIENT'S HEAD IN THE CERETOM DEPENDS UPON THE PATIENT'S CONDITION SINCE HE/SHE IS SCANNED ON HIS OWN BED. WITH THE PATIENT'S HEAD TILTED IN THE Y-DIRECTION, THE RIGHT HEMISPHERE LOOKED BIGGER AS THE SCAN TRAVEL TOWARD THE TOP OF THE SKULL. THE TILT CAUSED ASYMMETRY IN THE IMAGE WHICH AFFECTED THE BONE CORRECTION ON THE LEFT SIDE OF THE IMAGE. AN IMPLANTED METAL ARTIFACT IS KNOWN IN CT IMAGING TO AFFECT THE CT-VALUE IN THE VICINITY OF THE IMPLANT. THE EFFECT DEPENDS ON THE LOCATION, SIZE AND DENSITY OF THE METAL OBJECT. THE CERETOM USER MANUAL PROVIDES WRITTEN INSTRUCTION ON PROPER HEAD POSITIONING. THE POSITION OF THE SCAN NEAR THE TOP OF THE SKULL CAN HAVE A GREAT INFLUENCE ON THE CORRECTION DUE TO THE LARGE GRADIENT OF THE SKULL.

    Description of Event or Problem · 1

    A PATIENT SCAN WAS MISDIAGNOSED AS A STROKE. AS A RESULT, THE DOCTOR REQUESTED A FOLLOW UP SCAN ON A FIXED SCANNER WHICH SHOWED NO SIGN OF A STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERETOM CT SCANNER JAK NEUROLOGICA CORPORATION NL3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR