BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALM

    MDR report key: 1130623 · Received August 8, 2008

    Report

    Report Number
    1225700-2008-00129
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 12, 2008
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, A RUBBER END CAP (CLOSE TO THE LIGHT HEAD, ON THE BRACKET) FELL INTO THE OPERATING FIELD. NO CLINICAL CONSEQUENCES HAVE BEEN REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM FSY FSY MAQUET S.A. PRISMALIX *

    Patients

    Seq Age Sex Outcome Treatment
    1 *