BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCEA 10

    MDR report key: 11900438 · Received May 28, 2021

    Report

    Report Number
    9710055-2021-00208
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    March 17, 2021
    Report Date
    September 28, 2021
    Manufacturer
    MAQUET SAS
    Product Code
    KZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH LUCEA 10 DEVICE. AS IT WAS STATED, THE COVER WAS BROKEN OFF. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY DETACHMENT OF PART OR PARTICLES MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE LIGHT DID NOT MEET ITS SPECIFICATION AS THE COVER WAS BROKEN OFF AND IT CONTRIBUTED TO EVENT. THERE IS NO INFORMATION WHETHER THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. ACCORDING TO INFORMATION PROVIDED BY SALES AND SERVICE UNIT, THE COVER WAS BROKEN DUE TO CRASH. PROBABLE ROOT CAUSE IS IMPROPER USE OR IMPROPER HANDLING OF EQUIPMENT. IT IS NECESSARY TO REFER TO THE INSTRUCTION MANUAL FOR MORE INFORMATION (IFU 01701 EN 10 2021-03-17 PAGE 21). WE BELIEVE THAT THIS TYPE OF OUR DEVICES ARE PERFORMING CORRECTLY IN THE MARKET.

    Description of Event or Problem · 0

    MANUFACTURER 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 (B)(6) 2021 GETINGE BECAME AWARE OF AN ISSUE WITH LUCEA 10 DEVICE. AS IT WAS STATED, THE COVER WAS BROKEN OFF. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY DETACHMENT OF PART OR PARTICLES MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796646 LUCEA 10 DEVICE, MEDICAL EXAMINATION, AC POWERED KZF MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1