BEUDAMED
    FDA Adverse Event Other Summary report: N

    CASTLE

    MDR report key: 1351730 · Received March 25, 2009

    Report

    Report Number
    3019090-2009-00002
    Event Type
    Other
    Date Received
    March 25, 2009
    Date of Event
    February 25, 2009
    Report Date
    February 25, 2009
    Manufacturer
    MAQUET INC.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESPONDING TO A SERVICE CALL A MAQUET INC., FIELD SERVICE REPRESENTATIVE WAS TOLD THAT A SCREW HAD FALLEN OUT OF THE CUPOLA CAP OF THE SURGICAL LIGHT. UPON INSPECTION OF THE LIGHT, THE SERVICE REPRESENTATIVE FOUND NO MECHANICAL DEFECTS OR ANOMALIES WITH THE LIGHT. THE TECHNICIAN DID NOTE THAT THERE WERE OTHER LOOSE SCREWS ON THE LIGHT ASSEMBLY AND SUSPECTS IMPROPER MAINTENANCE OF THE LIGHT. THE SERVICE TECHNICIAN REPLACED THE SCREW AND TIGHTENED DOWN THE REMAINING LOOSE SCREWS. THUS, RESOLVING THE PROBLEM FOR THE CUSTOMER. MAQUET INC. HAS RECENTLY ENTERED INTO A SERVICE AGREEMENT WITH THIS HOSPITAL AND WILL NOW BE MAINTAINING THESE LIGHTS PER THE MANUFACTURER'S SPECIFICATION.

    Description of Event or Problem · 1

    PRIOR TO THE START OF A SURGICAL PROCEDURE, A SCREW FELL OUT OF THE CUPLOLA CAP OF A CASTLE LIGHT. THERE WAS NO CONSEQUENCE TO THE PATIENT AND THE PROCEDURE WAS ABLE TO PROCEED WITHOUT INTERRUPTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTLE FSY MAQUET INC. 2062

    Patients

    Seq Age Sex Outcome Treatment
    1