BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCEA 40

    MDR report key: 11956913 · Received June 8, 2021

    Report

    Report Number
    9710055-2021-00214
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 20, 2021
    Report Date
    July 21, 2021
    Manufacturer
    MAQUET SAS
    Product Code
    KZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH EXAMINATION LIGHT ¿ LUCEA 40. AS IT WAS STATED, THE HOUSING WAS BROKEN WHAT COULD HAVE LED TO THE HEADLIGHT'S DETACHMENT. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING MAY LEAD TO SERIOUS INJURY. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE LIGHT DID NOT MEET ITS SPECIFICATION AS THE COVER WAS DAMAGED AND PARTICLES WERE MISSING AND IT CONTRIBUTED TO EVENT. THERE IS NO INFORMATION WHETHER THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. THE CRACKS DETECTED AT THE EDGE OF THE FIXING HOLES OF TRANSPARENT HOUSING AND HANDLE INTERFACE WERE PROBABLY CAUSED BY THE INCOMPATIBILITY OF THE CLEANING PROTOCOL OR AN ABNORMAL USE. THE USER MANUAL 01701 EN 10 PAGE 27 ¿ 29 DESCRIBES HOW TO CLEAN AND DISINFECT THE LIGHT HEADS. THIS DOCUMENT INCLUDES SOME RECOMMENDED PRODUCTS AND SOME PROHIBITED PRODUCTS. IN ORDER TO AVOID TORQUES APPLIED ON THE TRANSPARENT HOUSING DURING USE, IFU 01701 EN 10 PAGE 23-24 MENTIONS TO HANDLE THE LIGHT HEAD BY THE HANDLE. THE CLEANING AND HANDLING TESTS PERFORMED BY GETINGE (REF. CRE 12-085) DID NOT LEAD TO CRACKS AS REPORTED IN THE COMPLAINTS. TO PREVENT SIMILAR EVENT THE USER MANUAL 01701 EN 10 PAGE 20 MENTIONS TO CHECK THE LIGHT HEAD DURING DAILY INSPECTION. WE BELIEVE THAT THIS TYPE OF OUR DEVICES ARE PERFORMING CORRECTLY IN THE MARKET.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON 26TH MAY, 2021 GETINGE BECAME AWARE OF AN ISSUE WITH EXAMINATION LIGHT ¿ LUCEA 40. AS IT WAS STATED, THE HOUSING WAS BROKEN WHAT COULD HAVE LED TO THE HEADLIGHT'S DETACHMENT. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING MAY LEAD TO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855864 LUCEA 40 DEVICE, MEDICAL EXAMINATION, AC POWERED KZF MAQUET SAS ARD568601997

    Patients

    Seq Age Sex Outcome Treatment
    1