BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFINIUM AMX 700

    MDR report key: 1525362 · Received November 6, 2009

    Report

    Report Number
    2126677-2009-00047
    Event Type
    Injury
    Date Received
    November 6, 2009
    Date of Event
    October 12, 2009
    Report Date
    October 12, 2009
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZL
    PMA / PMN Number
    K052897
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    GE'S INVESTIGATION CONSISTED OF THE FOLLOWING METHODOLOGIES: DEVICE EVALUATION: VISUAL INSPECTION OF THE DEVICE BY THE FIELD ENGINEER REVEALED NO EVIDENCE OF MALFUNCTION OR PRODUCT ISSUE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE WRIST FRACTURE. THE DIGITAL DETECTOR WEIGHS APPROX 13 LBS, WHICH IS WELL WITHIN THE LIMITS OF NORMAL HOSP PRACTICES FOR A HEALTHY INDIVIDUAL. CUSTOMER SITE INTERVIEW: THE CUSTOMER SITE REPORTED THAT THE TECHNOLOGIST HAS A PRE-EXISTING KEIBOCK'S DISEASE. THIS DISORDER (ALSO CALLED OSTEONECROSIS) INVOLVES INTERRUPTION OF THE BLOOD SUPPLY TO THE LUNATE (ONE OF THE SMALL BONES OF THE HAND NEAR THE WRIST). IN ADDITION, THE SITE INDICATED THAT THE TECHNOLOGIST WAS LIFTING THE DETECTOR WITH ONE HAND DURING A THREE-DAY PERIOD. LABELING REVIEW: LABELING REVIEW DEMONSTRATES THAT THE WEIGHT OF THE DETECTOR IS INDICATED ON THE DEVICE. FURTHERMORE, THE OPERATOR MANUAL FOR THE SYSTEM PROVIDES INSTRUCTIONS TO THE OPERATOR TO USE BOTH HANDS WHEN MANIPULATING THE DETECTOR TO THE CORRECT ANATOMICAL POSITION FOR THE EXAM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN X-RAY TECHNOLOGIST SUSTAINED A WRIST FRACTURE AFTER HANDLING THE DEFINIUM AMX 700 DIGITAL DETECTOR. ACCORDING TO THE CUSTOMER SITE, THE TECHNOLOGIST HAD BEEN CARRYING OUT NORMAL WORK DUTIES FOR THREE DAYS, AND HAD BEEN LIFTING THE DETECTOR WITH ONE HAND WHILE POSITIONING PTS. DURING THIS PERIOD, THE TECHNOLOGIST REPORTED OF FEELING PAIN IN HER WRIST AND ALLEGED THAT IT WAS DUE TO THE WEIGHT OF THE DETECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFINIUM AMX 700 IZL GE MEDICAL SYSTEMS, LLC 5151481-3

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention