BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 1518432 · Received October 23, 2009

    Report

    Report Number
    9710055-2009-00011
    Event Type
    Other
    Date Received
    October 23, 2009
    Date of Event
    September 25, 2009
    Report Date
    September 25, 2009
    Manufacturer
    MAQUET S.A.
    Product Code
    FTD
    PMA / PMN Number
    K932451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL'S BIOMEDICAL ENGINEER REPAIRED THE BROKEN HANDLE AND VERIFIED PROPER OPERATION OF THE SURGICAL LIGHT. THE BIOMEDICAL ENGINEER EXAMINED THE HANDLES OF THE REMAINING HANAULUX 2005 LIGHTS AT THE FACILITY AND VERIFIED THE REMAINING HANDLES WERE IN GOOD CONDITION. AFTER THE EVAL OF THE BROKEN HANDLE COMPONENTS, MAQUET SA BELIEVES THE MOST PROBABLE EXPLANATION FOR THIS EVENT IS THE APPLICATION OF AN EXCESSIVE FORCE TO THE HANDLE THAT IS INCONSISTENT WITH THE NORMAL OPERATION OF THE LIGHT. THERE IS INSUFFICIENT EVIDENCE TO DETERMINE THE EXACT ROOT CAUSE OF THE INCIDENT. HOWEVER, THIS TYPE OF BREAK COULD RESULT FROM A COLLISION WITH ANOTHER LIGHT OR OPERATING ROOM DEVICE. HANAULUX 2005I LIGHTS COMPLY WITH THE STANDARDS FOR LUMINARIES - (B) (4) AND (B) (4) - THAT INCLUDE LOAD TESTS ON THE HANDLE. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET S.A. PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    DURING SURGERY, THE SURGEON ADJUSTED THE OPERATING LIGHT AND IMMEDIATELY AFTER, THE LIGHT CENTRAL HANDLE BROKE OFF, FELL ON SURGEON'S HEAD AND ONTO THE OPEN WOUND OF THE PT. THE SURGEON WAS NOT INJURED AND THE PT WAS GIVEN ADDED ANTIBIOTIC. (B) (4). (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM FTD MAQUET S.A. HANAULUX 2000

    Patients

    Seq Age Sex Outcome Treatment
    1