BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGENIEUX

    MDR report key: 3922412 · Received June 3, 2014

    Report

    Report Number
    9710055-2014-00037
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K904965
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN (FST) INSPECTED THE DEVICE AND FOUND SEVERAL DAMAGED PARTS. THERE WERE MISSING LENSES AND BROKEN GASKETS. THE CUSTOMER ALSO RELATED TO THE FST THAT NO REGULAR MAINTENANCE HAD OCCURRED SINCE THE DEVICE WAS INSTALLED. MAQUET BELIEVES THAT THE DETERIORATION OF THE PERIPHERAL SEAL WAS THE RESULT OF A LACK OF PREVENTIVE MAINTENANCE. THE ANGENIEUX SERIES OPERATING MANUAL SPECIFIES THAT ANNUAL MAINTENANCE AND INSPECTIONS SHOULD BE PERFORMED. THE FST SUGGESTED TO THE CUSTOMER THAT THE DEVICE SHOULD NOT BE USED UNTIL IT IS REPAIRED OR REPLACED. MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DEBRIS WERE FALLING FROM THE LIGHTS INTO THE STERILE FIELD. NO PATIENT OR USER HARM WERE REPORTED TO MAQUET. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323288 ANGENIEUX FSY MAQUET SAS NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1