BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 15833454 · Received November 21, 2022

    Report

    Report Number
    9710055-2022-00482
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    November 18, 2022
    Report Date
    November 21, 2022
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. IT WAS STATED A HANDLE WAS MISSING ON LIGHT HEAD. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. ACCORDING TO THE INFORMATION PROVIDED BY GETINGE TECHNICIAN, THE DEFECTIVE PART WAS REPLACED AND REPAIR IS COMPLETED. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AS MISSING HANDLE ON LIGHT HEAD COULD BE TREATED AS TECHNICAL DEFICIENCY AND IN THIS WAY THE DEVICE CONTRIBUTED TO THE EVENT. THERE IS NO INFORMATION AVAILABLE WHETHER THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION, IT WAS FOUND THAT IN THE PAST THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY NOR DEATH. COMPARING THE NUMBER OF CLAIMED DEVICES TO THE INSTALL BASE, WE CONCLUDE THAT THE FAILURE RATIO IS LOW FOR MISSING HANDLE. A ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERT AT MANUFACTURING SITE. AS STATED, THE SEPARATION OF THE CAMERA HAS BEEN CAUSED BY A TEARING OF THE BASE FIXING HOLE, DUE TO REPETITIVE STRESSES DURING THE MANIPULATION OF THE CAMERA. THE INVOLVED PLASTIC PART 567801057 IN PPS FORTRON HAS BEEN REPLACED BY A STEEL PART 567801181 IN JANUARY 2011 UNDER MODIFICATION FILE #E090520. THE KIT 367265555, INCLUDING THE BASE 567801181 IN STEEL WAS AVAILABLE FROM JULY 2010. MAQUET SAS RECOMMENDS UPDATING THE SIMILAR CAMERAS, IN PREVENTIVE MEASURE, IN THIS FACILITY. CURRENTLY THE CAMERAS # 567203945, 567203944, 567501246, 567501248 ARE NOT ANY MORE DISTRIBUTED. FROM JANUARY 2011 ALL THE CAMERAS SUPPLIED ARE EQUIPPED WITH THE STEEL BASE. WE BELIEVE THAT ALL REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. 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

    ON 18TH NOVEMBER, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. IT WAS STATED A HANDLE WAS MISSING ON LIGHT HEAD. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING 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
    349320 POWERLED LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown