BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCEA 40

    MDR report key: 11847923 · Received May 19, 2021

    Report

    Report Number
    9710055-2021-00195
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    May 17, 2021
    Report Date
    June 24, 2021
    Manufacturer
    MAQUET SAS
    Product Code
    KZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH LUCEA 40 LIGHT. THE CRACK OF A COVER AND TRANSFORMER BOX OCCURRED, RESULTING IN MISSING PLASTIC PARTICLES. ALSO INFORMATION THAT THE LIGHT FELL TO THE GROUND WAS PROVIDED. 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 OR PARTS FALLING OFF MAY CAUSE POTENTIAL INFECTION. THE REPLACEMENT OF AFFECTED PART WILL BE DONE AFTER BUDGET APPROVAL. THE EQUIPMENT IS OUT OF USAGE. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE LIGHT DID NOT MEET ITS SPECIFICATION AS CUPOLA AND TRANSFORMER BOX WERE DAMAGED AND IN THIS WAY DEVICE CONTRIBUTED TO EVENT. WE HAVE NOT RECEIVED INFORMATION WHETHER THE DEVICE WAS BEING USED FOR PATIENT TREATMENT AT THE TIME WHEN THE EVENT OCCURRED. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE TYPE, WE HAVE BEEN ABLE TO CONFIRM THAT THE INVESTIGATED ISSUE HAS NEVER LED TO SERIOUS INJURY OR WORSE, TO OUR KNOWLEDGE. ON A LUCEA 40 MOBILE THE LIGHT HEAD AND THE POWER BOX WERE FOUND BROKEN BECAUSE THE DEVICE FELL TO THE FLOOR. THIS FALL IS NOT DUE TO THE PRODUCT INSTABILITY AS THE CUSTOMER PRETENDED. THE MOST PROBABLE CAUSE OF THIS FALL IS A MISUSE. THE TEST REPORT RE20-78B SHOWS THAT THE LUCEA 40 MOBILE IS COMPLIANT TO THE STANDARD IEC 60601-1 ED. 3.1 § 9.4.2.2. THE USER MANUAL INDICATES HOW TO MANIPULATE SAFELY THE DEVICE. MOREOVER, A WARNING STIPULATES THAT THE MOBILE MAY TIP OVER IF A PERSON LEANS ON IT. WE BELIEVE THAT ALL REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. GIVEN THE CIRCUMSTANCES AND AFTER OUR REVIEW OF COMPLAINT RATIO BEHAVIOR OF THIS NATURE, WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME. THE CORRECTION OF B5. DESCRIBE EVENT OR PROBLEM DEEMS REQUIRED. THIS IS BASED ON INFORMATION PROVIDED FROM SERVICE UNIT. PREVIOUS B5. DESCRIBE EVENT OR PROBLEM: ON 17TH MAY 2021, GETINGE BECAME AWARE OF AN ISSUE WITH LUCEA 40 LIGHT. THE CRACK OF A COVER OCCURRED, RESULTING IN MISSING PLASTIC PARTICLES. 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. CORRECTED B5. DESCRIBE EVENT OR PROBLEM: ON 17TH MAY 2021, GETINGE BECAME AWARE OF AN ISSUE WITH LUCEA 40 LIGHT. THE CRACK OF A COVER AND TRANSFORMER BOX OCCURRED, RESULTING IN MISSING PLASTIC PARTICLES. ALSO INFORMATION THAT THE LIGHT FELL TO THE GROUND WAS PROVIDED. 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 OR PARTS FALLING OFF MAY CAUSE POTENTIAL INFECTION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. THE CORRECTION OF D4 SERIAL # FIELD DEEMS REQUIRED. THIS IS BASED ON THE INFORMATION PROVIDED FROM THE SERVICE UNIT. PREVIOUS D4 SERIAL # (B)(6). CORRECTED D4 SERIAL # (B)(6).

    Description of Event or Problem · 0

    ON 17TH MAY 2021, GETINGE BECAME AWARE OF AN ISSUE WITH LUCEA 40 LIGHT. THE CRACK OF A COVER AND TRANSFORMER BOX OCCURRED, RESULTING IN MISSING PLASTIC PARTICLES. ALSO INFORMATION THAT THE LIGHT FELL TO THE GROUND WAS PROVIDED. 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 OR PARTS FALLING OFF MAY CAUSE POTENTIAL INFECTION.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2021, GETINGE BECAME AWARE OF AN ISSUE WITH LUCEA 40 LIGHT. THE CRACK OF A COVER OCCURRED, RESULTING IN MISSING PLASTIC PARTICLES. 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
    745200 LUCEA 40 DEVICE, MEDICAL EXAMINATION, AC POWERED KZF MAQUET SAS ARD568601997

    Patients

    Seq Age Sex Outcome Treatment
    1