BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED 300+DFK

    MDR report key: 10038115 · Received May 8, 2020

    Report

    Report Number
    9710055-2020-00120
    Event Type
    Malfunction
    Date Received
    May 8, 2020
    Report Date
    June 25, 2020
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT HAS BEEN REPORTED WITH A DELAY DUE TO OUR RETROSPECTIVE EXAMINATION OF THE RECORD. AT THE TIME (2017) THE COMPLAINT WAS REVIEWED AND FOUND NOT TO BE REPORTABLE. CURRENT DAY, WE COMPARED THE RECORD WITH EQUIVALENT EVENTS, AND FOUND AN INCONSISTENCY WITH THE REPORTING DECISIONS. WITH THE CURRENT KNOWLEDGE AND THE CURRENT TEAM OF COMPLAINT HANDLERS, WE HAVE COME TO CONCLUDE THE EVENT SHOULD HAVE BEEN REPORTED. AS A REMEDIAL EFFORT, WE HAVE REPORTED IT NOW. GETINGE BECAME AWARE OF AN ISSUE WITH POWERLED 300+DFK. AS IT WAS STATED, SOME PAINT CHIPPING WAS NOTICED. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AND BASED ON THE POTENTIAL AS ANY PARTICLES OF PAINT FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY LEAD TO CONTAMINATION. DURING THE INVESTIGATION IT WAS FOUND THAT IN THE PAST THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY OR WORSE, TO DEATH. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT SINCE THE PAINT SURFACE DETACHED. NONE OF THE PROVIDED INFORMATION INDICATE THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. THE MOST LIKELY ROOT CAUSE IS RELATED TO WRONG CLEANING AND DISINFECTION OF THE DEVICE, HOWEVER WITHOUT FURTHER INFORMATION WE ARE NOT ABLE TO FULLY CONFIRM THE ROOT CAUSE. WE BELIEVE THAT DEVICES IN THE MARKET ARE PERFORMING CORRECTLY OVERALL. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THERE IS NO APPARENT TREND IN COMPLAINTS 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.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON 20TH SEPTEMBER, 2017 GETINGE BECAME AWARE OF AN ISSUE WITH POWERLED 300+DFK. AS IT WAS STATED, THE PAINT CHIPPING WAS NOTICED. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AND BASED ON THE POTENTIAL AS ANY PARTICLES OF PAINT FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY LEAD TO CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503251 POWERLED 300+DFK LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1