BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCEA 40

    MDR report key: 11738095 · Received April 28, 2021

    Report

    Report Number
    9710055-2021-00148
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 28, 2021
    Manufacturer
    MAQUET SAS
    Product Code
    KZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH LUCEA 40 LIGHT. THE HEAD LIGHT COVER WAS DAMAGED AND PARTICLES WERE MISSING, THE ISSUE WAS CONFIRMED BY A PHOTOGRAPHIC EVIDENCE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF MAY CAUSE POTENTIAL INFECTION. 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. IN THE TIME WHEN THE EVENT OCCURRED, THE DEVICE WAS BEFORE USE FOR PATIENT DIAGNOSIS. 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 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 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 15TH APRIL 2021, GETINGE BECAME AWARE OF AN ISSUE WITH LUCEA 40 LIGHT. THE HEAD LIGHT COVER WAS DAMAGED AND PARTICLES WERE MISSING, THE ISSUE WAS CONFIRMED BY A PHOTOGRAPHIC EVIDENCE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF MAY CAUSE POTENTIAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635194 LUCEA 40 DEVICE, MEDICAL EXAMINATION, AC POWERED KZF MAQUET SAS ARD568601997

    Patients

    Seq Age Sex Outcome Treatment
    1