BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET

    MDR report key: 1509332 · Received October 1, 2009

    Report

    Report Number
    9710055-2009-00010
    Event Type
    Other
    Date Received
    October 1, 2009
    Date of Event
    September 1, 2009
    Report Date
    September 1, 2009
    Manufacturer
    MAQUET S.A.
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE TECHNICAL EVAL AND THE DECLARATION MADE BY THE HOSPITAL, THE ROOT CAUSE OF THIS ADVERSE EVENT IS A LACK OF MAINTENANCE ON AN OLD SURGICAL LIGHT SYSTEM. A MAQUET TECHNICIAN WENT IN THE HOSPITAL TO INVESTIGATE THIS INCIDENT, DURING THE INSPECTION OTHER OPERATING ROOMS WERE CHECKED. ALL THE OPERATING ROOMS CHECKED WERE FOUND TO HAVE EITHER MISSING PARTS OR LOOSE DOWN TUBES BOLTS. DURING THE INSERTION, THE SERVICE TEAM REPLACED ALL BOLTS AND SECURED THEM IN PLACE. ACCORDING TO THE MAQUET MAINTENANCE PROGRAM (B) (4), IT IS REQUESTED TO CHECK ALL THE SCREWS ON THE SUSPENSION TUBE. THIS MAINTENANCE SHOULD BE YEARLY DONE BY QUALIFIED PERSONNEL. MAQUET HAS NEVER SERVICED THE LIGHTS IN THIS HOSPITAL. THE HOSPITAL ELECTED TO HAVE MAQUET REPLACE THE UNIT THAT FELL WITH A NEW LIGHTING SYSTEM. THIS WORK WAS COMPLETED ON 09/10/2009. 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

    MAQUET SA HAS BEEN NOTIFIED THAT A SURGICAL LIGHT CONFIGURATION FELL DOWN. ONE WEEK BEFORE THE INCIDENT DURING A SURGICAL PROCEDURE, ONE OF THE DOWN TUBE SCREWS OF THE SURGICAL LIGHT SHEERED OFF AND HIT A SURGEON ON THE HEAD. THE HOSPITAL'S BIOMEDICAL ENGINEER EXAMINED THE LIGHT AND FOUND A SCREW MISSING. THE BIOMEDICAL ENGINEER IS REPORTED TO HAVE RECOMMENDED TO SHUT DOWN THE OPERATING ROOM WHILE THE REPLACEMENT SCREWS WERE ORDERED. HOWEVER, THE OR STAFF WENT AND USED THE OPERATING ROOM. WHEN THE LIGHT FELL DOWN, ONE EMPLOYEE WAS STRUCK IN THE SHOULDER AND ANOTHER EMPLOYEE WAS ALSO ALLEGED TO HAVE SUFFERED ABRASIONS. (B) (4). (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET FTD MAQUET S.A. ECL 751

    Patients

    Seq Age Sex Outcome Treatment
    1