BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCEA 100

    MDR report key: 7855069 · Received September 7, 2018

    Report

    Report Number
    9710055-2018-00081
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Date of Event
    August 8, 2018
    Report Date
    November 5, 2018
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET SAS BECAME AWARE OF AN INCIDENT WITH A SURGICAL LIGHT LUCEA DEVICE. AS IT WAS STATED THERE APPEARS TO BE AN ISSUE WITH BRACKET OCCURRED AND THE PAINT WAS ALSO CHIPPING. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. NONE OF THE PROVIDED INFORMATION INDICATE THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. REVIEWING THE ISSUE WE FOUND THAT MAQUET SAS INITIATED A DESIGN CHANGE REQUEST #140805 WHERE THE MANUFACTURING PROCESS OF THE BRACKET WAS MODIFIED SINCE MARCH, 2015. HOWEVER DURING OUR INVESTIGATION IT WAS FOUND THAT THE ISSUE INVESTIGATED HEREIN APPEARS TO BE A SINGLE ISOLATED EVENT AT THIS TIME. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074 EXEMPTION # E2018005. GETINGE USA SALES, LLC (B)(4). CONTACT PERSON: (B)(6).

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074. EXEMPTION # E2018005. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2018 MAQUET SAS BECAME AWARE OF AN INCIDENT WITH ON OF SURGICAL LIGHTS- LUCEA 100. AS IT WAS STATED, PAINT CHIPPING OCCURRED. THE ISSUE WILL BE INVESTIGATED AS ANY PARTICLE FALLING MIGHT BE A SOURCE OF CONTAMINATION. MANUFACTURER REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE IS ESTABLISHED BY MANUFACTURING SITE HOWEVER, IT NEEDS TO BE CONFIRMED. (B)(4). EXEMPTION # E2018005. (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695116 LUCEA 100 LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD368614998

    Patients

    Seq Age Sex Outcome Treatment
    1