BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SA

    MDR report key: 2223478 · Received July 12, 2011

    Report

    Report Number
    9710055-2011-00004
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K040735
    Removal / Correction Number
    Z-0182-188-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN VISITED THE HOSPITAL AND EVALUATED THE DEVICE. WE FOUND THAT THE METAL STRUCTURE OF THE ONDAL ACROBAT 2000, DOUBLE FORK SPRING ARM HAD BROKEN AT THE JUNCTION WITH THE CUPOLA. HE REPLACED THE SPRING ARM WITH A NEW ONE. THIS MALFUNCTION WAS PREVIOUSLY ADDRESSED IN THE U.S. THROUGH A DEVICE CORRECTION: FDA NUMBER Z-0182-188-2010. (B)(4). THIS CUSTOMER IN (B)(6) RECEIVED THE FIELD SAFETY NOTICE ISSUED BY MAQUET (B)(4) IN (B)(6) 2010, BUT DID NOT FOLLOW THE RECOMMENDATIONS FROM MAQUET TO VERIFY THE WELD SEAMS AND REPLACE THE ARM IN CASE OF CRACKED WELD SEAM DETECTED. 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

    CUSTOMER REPORTED THAT AN XTEN SPRING ARM BROKE. THE CUPOLA WAS RETAINED BY ITS CABLES. NO INJURIES WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET SA FSY MAQUET SAS X10 DF DUO

    Patients

    Seq Age Sex Outcome Treatment
    1