BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 1398194 · Received May 28, 2009

    Report

    Report Number
    9710055-2009-00005
    Event Type
    Other
    Date Received
    May 28, 2009
    Date of Event
    April 28, 2009
    Report Date
    April 28, 2009
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    PMA / PMN Number
    K040735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE MAQUET REPRESENTATIVE VISITED THE HOSPITAL, AND EVALUATED THE DEVICE. THE SCREW THAT FELL IS USED TO FIX THE LOWER COVER ON THE CUPOLA. THE TECHNICIAN FOUND ALL THE PARTS OF THE ASSEMBLY IN GOOD CONDITION. HE REPAIRED THE DEVICE AND VERIFIED THE OTHER UNITS IN THE HOSPITAL. HE WAS NOT ABLE TO REPRODUCE THE PROBLEM, NOR DETERMINE THE CAUSE. THIS IS THE FIRST CASE REPORTED TO MAQUET, ALL UNITS WITH SIMILAR DESIGN INSTALLED ON THE FIELD, A NEGLIGIBLE INCIDENT RATE. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING 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 A SURGICAL PROCEDURE, WHILE THE PT WAS ON TABLE, ONE SCREW FELL FROM THE SURGICAL LIGHT. NO INJURIES WERE REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM FSY MAQUET S.A. X'TEN

    Patients

    Seq Age Sex Outcome Treatment
    1