BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 14159777 · Received April 20, 2022

    Report

    Report Number
    9710055-2022-00129
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    April 15, 2022
    Report Date
    April 20, 2022
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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 POWERLED SURGICAL LIGHT. AS IT WAS STATED, SPRING ARM DUST COVER FELL PRIOR TO SURGERY ONTO A PATIENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF MAY CAUSE CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET THE MANUFACTURERS SPECIFICATION DUE TO DETACHMENT OF SPRING ARM¿S COVER AND IT CONTRIBUTED TO THE EVENT. ACCORDING TO THE PROVIDED INFORMATION, UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. THE POSSIBLE ROOT CAUSES OF THE ISSUE WITH COVERS ARE: - NON-CONFORMITY OF THE METAL COVERS ASSEMBLY. - DEGRADATION OF THE METAL COVERS. - IMPROPER USE (COLLISION WITH ANOTHER DEVICE). MAQUET SAS ANALYSIS SHOWS THAT THE METAL STRIP COMES OUT OF THE COVERS WHEN IT IS NOT CLIPPED PROPERLY. IN THE SCOPE OF OUR CONTINUOUS IMPROVEMENT POLICY, MAQUET SAS INITIATED A MODIFICATION FILE TO INCLUDE THIS DUST COVER FITTING PROCEDURE IN THE TECHNICAL DOCUMENTATIONS WITH ALL SPRING ARMS. GETINGE 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 15TH APRIL, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH POWERLED SURGICAL LIGHT. AS IT WAS STATED, SPRING ARM DUST COVER FELL PRIOR TO SURGERY ONTO A PATIENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF 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
    2584373 POWERLED LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown