BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAULUX 2005I

    MDR report key: 6569117 · Received May 16, 2017

    Report

    Report Number
    9710055-2017-00033
    Event Type
    Malfunction
    Date Received
    May 16, 2017
    Date of Event
    April 19, 2017
    Report Date
    May 15, 2018
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    MAQUET SAS BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- HANAULUX 2005I DEVICE. IT WAS STATED THAT THE SAFETY RING BROKE AND LIGHT HEAD FELL ON THE GROUND AFTER 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 NOT 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. THE DEVICE INVOLVED IN THE CURRENT INCIDENT HAS BEEN IN USE FOR ABOUT 20 YEARS BEFORE THE EVENT OCCURRED. 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, MAY DISTORT OR DETERIORATE THROUGH THE USE OF AGGRESSIVE CLEANING PRODUCTS OR DISINFECTANTS. PLEASE NOTE THAT THE DEVICE WAS INSTALLED IN 1997, IT IN USE FOR 20 YEARS UNTIL THE EVENT OCCURRED. 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. 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 COULD HAVE BEEN AVOIDED. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, (B)(4). EXEMPTION # E2018005. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED AFTER INVESTIGATION RESULT.

    Description of Event or Problem · 1

    REF # (B)(4).

    Description of Event or Problem · 1

    REF # (B)(4).

    Description of Event or Problem · 1

    REF # (B)(4).

    Description of Event or Problem · 1

    ON THE (B)(6) MAQUEST (B)(4) BECAME AWARE OF AN INCIDENT WITH HANAULUX 2005I DEVICE. IT WAS STATED THAT LIGHTHEAD FELL AFTER THE SURGERY. THE PVC RING WHO KEEPS THE FIXATION PIECE ON HIS PLACE WAS BROKEN. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350961 HANAULUX 2005I LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1