BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DSX COLLIMATOR CART

    MDR report key: 8585 · Received January 10, 1994

    Report

    Report Number
    1122042-1993-09002
    Event Type
    Injury
    Date Received
    January 10, 1994
    Date of Event
    April 26, 1993
    Report Date
    November 19, 1993
    Manufacturer
    SOPHA MEDICAL
    Product Code
    HST
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE INCIDENT OCCURRED WHILE ATTEMPTING TO MOVE A COLLIMATOR EXCHANGE CART AAFTER REMOVING A MEDIUM ENERGY COLLOMATOR FROM THE DETECTOR OF A GAMMAACAMERA. TO PROVIDE SOME BACKGROUND INFORMATION, THE RM IN WHICH THIS CAMERA IS OPERATING HAS HAD A LONG HISTORY OF ISSUES SRELATING TO THE LEVELNESS OF THE FLOOR. DURING THE FIRST FEW YEARS OF OPERATION, THE CUSTOMER HAD BROKEN WHEELS ON THE COLLIMATOR CART DUE TO THE POOR LEVELNESS OF THE FLOOR AND THE LOCATION FOR STORAGE OF THIS CART. ON APRIL 7, 1992, SOPHA PROVIDED THE CUSTOMER A NEW CART WITH STRONGER WHEEL STRUCTURE TO HELP WITH THIS SITUATION. SINCE THEN THERE HAVE BEEN NO FAILURES WITH THESE WHEELS.AFTER REMOVING ATHE COLLIMATOR FROM THE DETECTOR, THE TECHNOLOGIST TRIED TO MOVE THE CART OVER ONE OF THE BAD AREAS OF THE FLOOR. SHE TURNED HER KNEE WHEN THE CART WOULD NOT MOVE. AAAT FIRST SHE DID NOT REALIZE ATHE SEROUSNESS OF THE INJURY, BUT AS TIME WENT BY, THE PAIN WAS MORE INTENSEE. THIS INCIDENT OCCURRED APRIL 20, 1993. SHE DID NOT NOTIFY SOPHA BECAUSE SHE FELT THE INJURY WAS NOT RELATED TO ANY PRODUCT ISSUES. HOWEVER SHE DID NOTIFY THE HOSPITAL OF THE INJURY AT THE TIME IT HAPPENED. THE HOSPITAL ATO DATE HAS NOT NOTIFIED SOPHA OF THIS INCIDENT. WE BECAAME AWARE OF THE INCIDENT WHEN, DURING A NON-RELATED MATTER, SHE MEENTIONED THAT SHE WILL HAVE SURGERY ON HER KNEE ON NOVEMBER 18, 1993.ALL OF THE INFORMATION TO DATE INDICATES THAT SOPHA MEDICAAL SYSTEMS' PRODUCT DID NOT CONTRIBUTE TO THE INCIDENT AND WERE NOT THE CAUSE OF ANY INJURY.THE FOREIGN MANUFACTURER HAS BEEN NOTIFIED OF THE INCIDENT.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DSX COLLIMATOR CART HST SOPHA MEDICAL DSX00034 FR

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention