BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCEA 50/100

    MDR report key: 17635064 · Received August 28, 2023

    Report

    Report Number
    9710055-2023-00604
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Report Date
    August 28, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE - EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER: NO. CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: N/A. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 100. IT WAS STATED THERE WAS A WATER PIPE RUNNING THROUGH THE CEILING, AND WATER LEAKED INTO THE BOARD, CAUSING THE BOARD TO SHORT CIRCUIT. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK. BASED ON AN INFORMATION GATHERED, DEVICE WAS REPAIRED AND RELEASED FOR USE. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. PROVIDED INFORMATION DOES NOT INDICATE IF UPON THE EVENT OCCURRENCE, THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERT AT MANUFACTURER¿S. THE ANALYSIS IS FOLLOWING: ACCORDING TO THE INFORMATION PROVIDED THE PRESENCE OF WATER IN THE SURGICAL LIGHT IS THE RESULT OF A WATER LEAKAGE FROM THE CEILING OF THE FACILITY ¿THERE WAS A WATER PIPE RUNNING THROUGH THE CEILING, AND WATER LEAKED INTO THE BOARD, CAUSING THE BOARD TO SHORT CIRCUIT". IT IS A PHENOMENON EXTERNAL TO THE DEVICE. THIS PROBLEM IS NOT RELATED TO THE DEVICE, THE LUCEA SURGICAL LIGHT IS NOT SUPPLIED WITH WATER AND IS NOT A SOURCE OF A LEAK. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ON 21ST AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 100. IT WAS STATED THERE WAS A WATER PIPE RUNNING THROUGH THE CEILING, AND WATER LEAKED INTO THE BOARD, CAUSING THE BOARD TO SHORT CIRCUIT. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CONTACT OF WATER WITH LIVE PARTS MAY CAUSE ELECTRIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726343 LUCEA 50/100 LAMP, SURGICAL FTD MAQUET SAS ARD568603999

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown