BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCEA 50/100

    MDR report key: 10425094 · Received August 19, 2020

    Report

    Report Number
    9710055-2020-00334
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Report Date
    November 17, 2020
    Manufacturer
    MAQUET SAS
    Product Code
    FSS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50/100. AS IT WAS STATED, THE COMPONENTS WERE MISSING ON THE SURGICAL LIGHT. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY FALLING PARTS MIGHT CAUSE CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AS A PART WAS MISSING, AND IT CONTRIBUTED TO EVENT. NONE OF THE PROVIDED INFORMATION INDICATE THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT IN THE PAST THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY OR WORSE, TO DEATH. UNFORTUNATELY, MANUFACTURER DID NOT RECEIVE ENOUGH INFORMATION TO CONDUCT THE TECHNICAL INVESTIGATION. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE AND THEREFORE THE FACTORY INVESTIGATION REPORT CANNOT BE PERFORMED. IN CASE OF NEW RELEVANT INFORMATION, THE CASE WILL BE RECONSIDERED WE BELIEVE THAT ALL REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE PREVENTIVE MAINTENANCE WOULD HAVE BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. GIVEN THE CIRCUMSTANCES WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    ISSUE IS BEING INVESTIGATED BY MANUFACTURER. IT WAS OBSERVED DURING AN EXTERNAL AUDIT AT GETINGE (B)(4), THAT SERVICING PRACTICES AT GETINGE (B)(4) ARE NOT IN COMPLIANCE TO APPLICABLE REQUIREMENTS DUE TO IDENTIFIED GAPS IN QUALITY MANAGEMENT SYSTEM. SPECIFICALLY, UNANTICIPATED REPAIR ACTIVITIES WERE NOT SUBMITTED AS COMPLAINTS AND ASSESSED FOR REPORTING AS REQUIRED PER REGULATIONS AND AS A RESULT THIS REPORT WAS NOT SUBMITTED IN A TIMELY MANNER. GETINGE (B)(4) HAS APPROVED A COMPREHENSIVE REMEDIATION PLAN AND ALL UNANTICIPATED REPAIR ACTIVITIES WILL BE SUBMITTED AS COMPLAINTS. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON 5TH FEBRUARY, 2020 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50/100. AS IT WAS STATED, THE COMPONENTS WERE MISSING ON THE SURGICAL LIGHT. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY FALLING PARTS MIGHT CAUSE CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893186 LUCEA 50/100 LIGHT, SURGICAL, FLOOR STANDING FSS MAQUET SAS ARDLCA219002C

    Patients

    Seq Age Sex Outcome Treatment
    1