BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAULUX 2005

    MDR report key: 6998938 · Received November 3, 2017

    Report

    Report Number
    9710055-2017-00071
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 1, 2017
    Report Date
    April 30, 2018
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K932451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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). MAQUET SAS BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- HANAULUX 2005 DEVICE. IT WAS STATED THAT THE SAFETY RING BROKE AND LIGHT HEAD FELL ON THE GROUND DURING THE SURGERY. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. IN THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS BEING USED FOR THE PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THERE IS NO APPARENT TREND WITH THE ISSUE AT HAND AND THAT THE REPORTED SCENARIO HAS LED ONCE TO SERIOUS INJURY OR WORSE. IT WAS FOUND THAT THE POSSIBLE ROOT CAUSE OF THIS EVENT IS DEGRADATION OF THE PLASTIC SAFETY SLEEVE, WHICH AFTER A LONG PERIOD OF USE, CAN DISTORT OR DETERIORATE THROUGH THE USE OF AGGRESSIVE CLEANING PRODUCTS OR DISINFECTANTS. PLEASE NOTE THAT THE DEVICE WAS INSTALLED IN 1998, IT IN USE FOR 19 YEARS UNTIL THE EVENT OCCURRED. SINCE INSTALLATION THE DEVICE WAS MAINTAINED BY THE CUSTOMER¿S SERVICE PARTNER NOT BY THE SERVICE AUTHORIZED BY THE MANUFACTURER, LAST MAINTENANCE WAS PERFORMED ON DECEMBER 2016, THEREFORE 10 MONTHS BEFORE THE EVENT. THE MALFUNCTIONED PART ¿ A SAFETY SLEEVE - SHOULD BE CHECKED EVERY 6 MONTHS DURING RECOMMENDED MAINTENANCE AS DESCRIBED IN THE CHAPTER ¿INSPECTION BY THE OPERATOR¿ IN THE USER MANUAL FOR HLX 2000 DEVICE 56351039/E. AS PER INCIDENT SCENARIO WE CAN CONCLUDE THAT A DEVICE WAS NOT WELL MAINTAINED BY THE CUSTOMER SERVICE PARTNER, WHO DID NOT FOLLOW THE MANUFACTURER¿S RECOMMENDATIONS DESCRIBED ALIKE IN THE USER MANUAL AND TECHNICAL NOTICE. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT WOULD HAVE BEEN AVOIDED.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER # (B)(4).

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ISSUE WILL BE INVESTIGATED BY MANUFACTURING SITE.

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER # (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017 (B)(4) BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- HANAULUX 2005. AS IT WAS STATED, THE SAFETY RING BROKE AND THE LIGHT HEAD FELL ON THE GROUND. THERE WAS NO PATIENT INVOLVED HOWEVER WE DECIDED TO REPORT THIS ISSUE IN ABUNDANCE OF CAUTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779876 HANAULUX 2005 LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS 56076869

    Patients

    Seq Age Sex Outcome Treatment
    1