BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 1568499 · Received December 11, 2009

    Report

    Report Number
    9710055-2009-00017
    Event Type
    Other
    Date Received
    December 11, 2009
    Date of Event
    November 10, 2009
    Report Date
    November 12, 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. THIS LIGHT WAS LAST VERIFIED (STRESS TESTED) IN (B) (6) 2009, AFTER A SIMILAR ISSUE OBSERVED ON ANOTHER DEVICE. NO CRACKS WERE FOUND AT THIS TIME. A VISUAL EXAM REVEALED THAT THE HANDLE THAT BROKE HAD BEEN MODIFIED TO SUPPORT A DISPOSABLE HANDLE SUPPORT. THIS ADDITIONAL PART MIGHT HAVE WEAKENED THE HANDLE DURING USE. THIS MODIFICATION HAS NOT BEEN DONE UNDER THE CONTROL OF MAQUET, NOR APPROVED BY MAQUET. HANAULUX 2005I LIGHTS COMPLY WITH THE STANDARDS FOR LUMINAIRES - (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 ROOM SET UP, HOSP STAFF ADJUSTED THE OPERATING LIGHT, AND THE LIGHT HANDLE BROKE OFF. NO INJURY OR PT INVOLVEMENT WAS REPORTED. (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