BEUDAMED
    FDA Adverse Event Other Summary report: N

    CASTLE

    MDR report key: 1102169 · Received August 7, 2008

    Report

    Report Number
    3019090-2008-00001
    Event Type
    Other
    Date Received
    August 7, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    MAQUET INC.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 07/25/08, MANUFACTURING SERVICE REPRESENTATIVES VISITED THE CUSTOMER SITE TO INVESTIGATE THE INCIDENT AND FOUND THE RETAINING CLIP AND WASHER USED TO SECURE THE LIGHT HEAD ASSEMBLY TO THE SPRING ARM WERE MISSING. THESE COMPONENTS ARE CRITICAL TO THE SAFE OPERATION OF THE LIGHT. THE CLIP IS KEPT IN PLACE BY A SAFETY SLEEVE THAT COVERS THE CLIP AND PROTECTS THE CONNECTION AREA. THE SERVICE TEAM LOOKED FOR THE MISSING PARTS BUT FAILED TO LOCATED THEM. WHEN THE TEAM ASKED THE HOSPITAL STAFF ABOUT THE MISSING CLIPS, THE HOSPITAL STAFF REPORTED THAT THEY WERE NOT AWARE OF ANY PARTS FALLING OUT OF THE LIGHT AT THE TIME OF THE INCIDENT. SERVICE REPRESENTATIVES IDENTIFIED GOUGES IN THE SPRING ARM EXTENSION THAT THE LIGHT HEAD ASSEMBLY ATTACHES TO. THESE GOUGES ALIGN WITH THE SCREWS FROM THE SAFETY SLEEVE. THIS SUGGESTS THAT THE SCREWS WERE KEEPING THE LIGHT TOGETHER AND NOT THE SAFETY CLIP AS MANDATED IN THE MANUFACTURER'S DIRECTIONS. BECAUSE THE SAFETY CLIPS WAS FOUND TO BE MISSING, THE SCREWS WERE THE ONLY MECHANICAL DEVICE KEEPING THE LIGHT ASSEMBLY TOGETHER. MAQUET, INC. CANNOT DETERMINE THE CONDITION OF THE LIGHTS PRIOR TO OR AT THE TIME OF INCIDENT AS THE CUSTOMER HIRED A THIRD PARTY CONTRACTOR TO INSTALL THE LIGHTS AND PERFORMED THEIR OWN MAINTENANCE. THE MANUFACTURER HAS DISCUSSED REPAIRS WITH THE CUSTOMER.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED THAT THE LIGHT HEAD ASSEMBLY HAD SEPARATED FROM ITS SPRING ARM ASSEMBLY. DURING THE FALL, THE CUPOLA GLANCED OFF THE HEAD OF A HOSPITAL EMPLOYEE. INFORMATION PROVIDED BY HOSPITAL STAFF INDICATED THAT THE EMPLOYEE INITIALLY REFUSED A MEDICAL EVALUATION, BUT EVENTUALLY WENT TO THE HOSPITAL'S ER FOR AN EXAMINATION WITHOUT ANY ASSISTANCE. NO FURTHER DETAILS WERE PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTLE FSY MAQUET INC. GCL500

    Patients

    Seq Age Sex Outcome Treatment
    1