BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDX

    MDR report key: 1645761 · Received March 19, 2010

    Report

    Report Number
    2183553-2010-00006
    Event Type
    Malfunction
    Date Received
    March 19, 2010
    Date of Event
    February 18, 2010
    Report Date
    February 18, 2010
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNCLEAR AT THIS TIME WHETHER OR NOT A DEVICE MALFUNCTION WAS INVOLVED. THE FIELD ENGINEER HAS CONFIRMED ALL OF THE IMAGES MIXED IN THE EXAM ARE ANNOTATED WITH THE 2ND PT'S INFO ON THEM (NAME, AGE, DATE OF BIRTH, EXAM NUMBER, ETC). AN INVESTIGATION IS ON GOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMAGES FROM ONE PT WERE MIXED INTO THE MR EXAMINATION OF ANOTHER PT. NO INJURY OR MISDIAGNOSIS WAS BEEN REPORTED. THE CUSTOMER ALLEGED THAT THE EVENT COULD BE DUE TO MODALITY WORKLIST; HOWEVER, THE INFO PROVIDED TO GE HEALTHCARE AT THIS TIME IS LIMITED. GE HEALTHCARE IS CURRENTLY MAKING ATTEMPTS TO OBTAIN ADDITIONAL DETAILS OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HDX LNH GE MEDICAL SYSTEMS, LLC 2395001-3

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK