BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 8000 BUCKY

    MDR report key: 6183 · Received June 3, 1993

    Report

    Report Number
    2126677-1993-00006
    Event Type
    Injury
    Date Received
    June 3, 1993
    Date of Event
    May 5, 1993
    Report Date
    May 10, 1993
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO G.E. THAT THE BUCKY TRAY PULLED OUT OUT OF THE BUCKY BECAUSE THE STOPS HAD FAILED ON THE BUCKY. APPARENTLY, THIS RESULTED IN THE TRAY LANDING ON THE TOE OF THE SERVICE ENGINEER, WHICH WAS THEN FRACTURED. EVIDENTLY, THE METAL TAB ON THE BUCKY ASSEMBLY HAD BROKEN OFF. THE INJURY RESULTED IN LOST WORK DAYS BY THE SERVICE ENGINEER.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: . SERVICE PROVIDED BY: DISTRIBUTOR. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: MECHANICAL PROBLEM, OTHER. CONCLUSION: DEVICE FAILURE INDIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 8000 BUCKY X-RAY TABLE BUCKY IXQ LIEBEL FLARSHEIM LF 8000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention