BEUDAMED
    FDA Adverse Event Other Summary report: N

    CASTLE

    MDR report key: 1490097 · Received October 1, 2009

    Report

    Report Number
    3019090-2009-00003
    Event Type
    Other
    Date Received
    October 1, 2009
    Date of Event
    September 18, 2009
    Report Date
    September 18, 2009
    Manufacturer
    MAQUET INC. (F.K.A. GETINGEUSA)
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE INITIAL INSPECTION, MAQUET SERVICE INFORMED THE CUSTOMER THAT THE CASTLE 2000 LIGHTS ARE AN OBSOLETE PRODUCT. MAQUET INC. SERVICE INSTRUCTED THE HOSPITAL STAFF WHAT IS REQUIRED PER THE USER MANUALS TO PROPERLY MAINTAIN THESE LIGHTS AND LEFT THE CUSTOMER WITH A LIST OF ITEMS REQUIRED TO RETURN THE LIGHTS TO THE ORIGINAL OPERATIONAL SPECIFICATIONS. GIVEN THE AGE OF THE LIGHT AND THE AVAILABILITY OF PARTS, THE HOSPITAL IS PRESENTLY REVIEWING ITS OPTIONS. MAQUET SERVICE HAS OFFERED ITS SERVICES TO THE CUSTOMER SHOULD THEY ELECT THE IMPLEMENT THE REPAIRS REQUIRED TO RETURN THESE LIGHTS TO A SAFE OPERATING CONDITION. IN A COMPLAINT ACKNOWLEDGEMENT LETTER, MAQUET HAS SUBMITTED TO THIS CUSTOMER A FORMAL STATEMENT COMMUNICATING THE NEED TO RETURN THESE LIGHTS TO THEIR ORIGINAL OPERATIONAL SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2009 MAQUET INC. SERVICE WAS REQUESTED TO CONDUCT A SITE INSPECTION AT THE (B)(6) MEDICAL CENTER. DURING THE SERVICE INSPECTION, IT WAS FOUND THAT THE SURGICAL LIGHTS IN BOTH OPERATING ROOM (B)(6) AND (B)(6) COULD OPERATE UNDER POTENTIALLY UNSAFE CONDITIONS. AT THE TIME OF INSPECTION, THE OPERATING ROOMS WERE NOT BEING USED. BOTH ROOMS HAVE AN INCORRECT LOCKING PIN IN PLACE; THE INCORRECT PINS ARE LOOSE. RE(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTLE FSY MAQUET INC. (F.K.A. GETINGEUSA) CASTLE 2000 SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1