BEUDAMED
    FDA Adverse Event Other Summary report: N

    CASTLE

    MDR report key: 1353553 · Received March 20, 2009

    Report

    Report Number
    3019090-2009-00001
    Event Type
    Other
    Date Received
    March 20, 2009
    Date of Event
    February 13, 2009
    Report Date
    February 13, 2009
    Manufacturer
    MAQUET INC.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6)2009, MAQUET INC., SERVICE REPRESENTATIVES VISITED THE CUSTOMER SITE TO INVESTIGATE THE INCIDENT. THE SERVICE REPRESENTATIVES WERE TOLD THE LIGHT HEAD HAD UNSCREWED FROM ARM AND WAS HANGING FROM ITS WIRES. PRIOR TO THEIR ARRIVAL, THE HOSPITAL'S ENGINEERING GROUP ATTEMPTED TO SCREW THE LIGHT BACK ON, BUT COULD NOT MAKE THE LAMP FUNCTION. MAQUET INC. SERVICE REPAIRED THE WIRING IN THE ARM AND WAS ABLE TO MAKE THE LAMP FUNCTION TO FACTORY SPECIFICATIONS. ANALYSIS OF THE FAILURE FOCUSES UPON THE STOP PIN IN THE COLLAR BEHIND THE CUPOLA. IT IS BELIEVED THIS PIN HAD BROKEN DUE TO IMPROPER USAGE. WITH THE PIN MISSING, THE CUPOLA WOULD BE ABLE TO SLIDE OUT OF THE SUPPORT ARM MOUNTING IN A MANNER CONSISTENT WITH THIS INCIDENT. DUE TO THE AGE AND DETERIORATED CONDITION THE LIGHT, MAQUET INC. SERVICE RECOMMENDED THAT THE CUSTOMER REPLACE THE LAMP AS A PREVENTATIVE MEASURE.

    Description of Event or Problem · 1

    ON (B)(6)2009, IT WAS REPORTED TO MAQUET INC.'S SERVICE REPRESENTATIVES BY THE HOSPITAL, THAT THE CUPOLA YOLK UNSCREWED FROM THE SUPPORT ARM AND WAS HANGING FROM WIRES. NO INJURIES WERE REPORTED AND THE LIGHT WAS NOT IN USE AT THE TIME OF EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTLE FSY MAQUET INC. 2410

    Patients

    Seq Age Sex Outcome Treatment
    1