BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDECAL

    MDR report key: 7633941 · Received June 25, 2018

    Report

    Report Number
    9617251-2018-00001
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    May 24, 2018
    Report Date
    June 21, 2018
    Manufacturer
    SEDECAL SA
    Product Code
    IYB
    UDI-DI
    08436046001930
    PMA / PMN Number
    K133782
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO CABLES AND PULLEY WERE TAKEN TO SEDECAL THE SAME MORNING OF MAY 25TH FOR A DEEPER ANALYSIS. THE REST OF THE DAMAGED EQUIPMENT, ONCE REMOVED, WAS TAKEN TO SEDECAL FACILITIES FOR FURTHER INVESTIGATION. ON MONDAY MAY 28TH, WE PROCEEDED TO ASSEMBLE THE PULLEY REMOVED IN A SIMILAR EQUIPMENT EXISTING AT SEDECAL FACILITIES. WHEN OPERATING THE EQUIPMENT IN SUCH CONDITIONS, AN UNUSUAL NOISE WAS DETECTED IN THE VERTICAL MOVEMENT. ONCE THE CAUSE OF THIS WAS ANALYZED, IT WAS FOUND THAT THE NOISE WAS DUE TO FRICTION BETWEEN THE TWO STEEL CABLES, WHICH HAD COME INTO CONTACT DUE TO THE GREATER WEAR PRODUCED IN ONE OF THE GROOVES OF THE PULLEY IN QUESTION WE WILL COMMUNICATE TO ALL CUSTOMERS A MANDATORY REVIEW OF THE ENTIRE INSTALLED BASE BY THE VARIOUS TECHNICAL SERVICES TO VERIFY THE STATUS OF THIS PULLEY AND THE TWO STEEL CABLES, PROCEEDING TO CHANGE THEM IN CASE OF DETECTING ANY DETERIORATION IN THE CABLES OR IRREGULAR OR EXCESSIVE WEAR OF THE PULLEY.

    Description of Event or Problem · 1

    THIS INCIDENT INVOLVES A MALFUNCTION IN A DIAGNOSTIC X-RAY SYSTEM, SPECIFICALLY THE OVERHEAD TUBE CRANE. THIS IS A CEILING MOUNTED DEVICE WHICH HOLDS THE X-RAY TUBE AND THE COLLIMATOR. THIS ASSEMBLY CAN BE MOVED BOTH HORIZONTALLY AND VERTICALLY. IN THIS CASE, THE ASSEMBLY FELL TO THE GROUND WITHOUT ANY COMMAND FROM THE OPERATOR TO DO THIS. HAD THERE BEEN A PERSON UNDERNEATH THE TUBE CRANE AT THE TIME, THAT PERSON COULD HAVE BEEN SEVERELY INJURED OR KILLED BECAUSE OF THE MASS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475413 SEDECAL DIAGNOSTIC X-RAY OVERHEAD TUBE STAND IYB SEDECAL SA NOVA FA 08436046001930

    Patients

    Seq Age Sex Outcome Treatment
    1