BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCEA 40

    MDR report key: 17743701 · Received September 14, 2023

    Report

    Report Number
    9710055-2023-00695
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Report Date
    September 14, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    KZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT SITE TELEPHONE IS (B)(6). THE INITIAL REPORTER WAS THE GETINGE TECHNICIAN. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE SPRING ARM COVER WAS MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE EXAMINATION LIGHT DID NOT MEET ITS SPECIFICATION, SINCE A MISSING CAP COVER COULD BE CONSIDERED AS TECHNICAL DEFICIENCY, AND IN THIS WAY THE DEVICE CONTRIBUTED TO THE EVENT. THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT UPON THE EVENT OCCURRENCE. ACCORDING TO THE INFORMATION GATHERED, THE ISSUE WAS DISCOVERED BY GETINGE TECHNICIAN DURING PREVENTIVE MAINTENANCE. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUE WE WERE ABLE TO ESTABLISH THAT THE RECEIVED INCIDENTS ARE OCCURRING AT A VERY LOW RATIO. WE HAVE BEEN ABLE TO CONFIRM THAT THE INVESTIGATED ISSUE HAS NEVER LED TO SERIOUS INJURY OR WORSE, TO OUR KNOWLEDGE. AS STATED BY SUBJECT MATTER EXPERT AT MAQUET SAS, THE MOST PROBABLE ROOT CAUSE OF THE BREAK OF THIS CAP IS REPEATED AND VIOLENT SHOCKS DURING THE USE OF THE DEVICE. ANOTHER PROBABLE ROOT CAUSE IS THAT THE CAP HAS BEEN FORGOTTEN OR DETERIORATED AFTER A READJUSTMENT OF THE SPRING ARM DURING THE MAINTENANCE OF MEDICAL DEVICE. THE YEARLY PREVENTIVE MAINTENANCE PROGRAM DOCUMENTED IN THE TECHNICAL MANUAL FOR LUCEA 10/40 (0170201 1K) ON PAGE 10 MENTIONS TO CHECK THE FIXING OF ALL CAPS. THE CAP MUST BE REINSTALLED DURING INSTALLATION OR AFTER THE MAINTENANCE PROCEDURE. MAQUET SAS STRONGLY ADVISES TO CHECK SIMILAR DEVICES IN THE HOSPITAL IN ORDER TO CHECK THE PRESENCE OF ALL SPRING ARMS CAPS. IF A MISSING CAP IS NOTICED, A NEW ONE SHOULD BE ORDERED AS SPARE PARTS. (BLUE 30 / LUCEA 40-50 : ARD569010102). WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION HAD BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME. INITIAL REPORTER: (B)(6).

    Description of Event or Problem · 0

    ON 12TH SEPTEMBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE SPRING ARM COVER WAS MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2225705 LUCEA 40 DEVICE, MEDICAL EXAMINATION, AC POWERED KZF MAQUET SAS ARD568601997

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown