BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECISION MPI POSITIONER

    MDR report key: 739257 · Received July 7, 2006

    Report

    Report Number
    9611343-2006-00016
    Event Type
    Other
    Date Received
    July 7, 2006
    Date of Event
    May 11, 2006
    Report Date
    July 7, 2006
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    KPR
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CONCERN IS STILL UNDERGOING INVESTIGATION. ALTHOUGH THE PRECISION MPI IS DESIGNED AND MANUFACTURED BY NRT IN DENMARK, IT IS SOLD EXCLUSIVELY TO GE. GE IS ALSO NOTIFYING NRT OF THE CONCERN.

    Description of Event or Problem · 1

    A CUSTOMER SITE HAS A CONCERN REGARDING A POSSIBLE PT COLLISION WITH THE IMAGE INTENSIFIER, WHILE PERFORMING A MYLOGRAM. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION MPI POSITIONER DIAGNOSTIC X-RAY KPR GE MEDICAL SYSTEMS SCS 2398238-286 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA