BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 11208409 · Received January 21, 2021

    Report

    Report Number
    9710055-2021-00018
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Report Date
    April 16, 2021
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. THE PURPOSE OF THIS SUBMISSION IS ALSO TO PROVIDE A CORRECTION OF VERSION OR MODEL # AND CATALOG# SECTIONS. D4: PREVIOUS VERSION OR MODEL #: ARD568370937. CORRECTED VERSION OR MODEL #: ARD568370907. PREVIOUS CATALOG #: ARD568370937. CORRECTED CATALOG #:ARD568370907.

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH POWERLED SURGICAL LIGHT. AS IT WAS STATED, THE COVER WAS DEFECTIVE. PHOTOGRAPHIC EVIDENCE REVEALED THAT THE DEVICE¿S DUST COVER WAS MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AS DUST COVERS SHOULD NOT FALL - AND THEREFORE IT CONTRIBUTED TO INCIDENT. THERE IS NO INDICATION THAT AT THE TIME WHEN THE EVENT OCCURRED, THE DEVICE WAS BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS. THE MANUFACTURER¿S SUBJECT MATTER EXPERTS HAVE INVESTIGATED THE ISSUE. THE POSSIBLE ROOT CAUSES OF THE ISSUE WITH DUST 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. WE BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT WOULD 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).

    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. DEVICE NOT RETURNED TO MANUFACTURER

    Description of Event or Problem · 1

    ON 19TH JANUARY, 2021 GETINGE BECAME AWARE OF AN ISSUE WITH POWERLED SURGICAL LIGHT. AS IT WAS STATED, THE COVER WAS DEFECTIVE. PHOTOGRAPHIC EVIDENCE REVEALED THAT DUST COVER WAS MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104015 POWERLED LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD568370907

    Patients

    Seq Age Sex Outcome Treatment
    1