BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 10669272 · Received October 13, 2020

    Report

    Report Number
    9710055-2020-00411
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Report Date
    November 30, 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

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. AS IT WAS STATED, UPPER JOINT COVER OF THE SPRING ARM 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 MIGHT CAUSE A CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AS THE DUST COVER SHOULD NOT FALL DURING PROCEDURE AND IT CONTRIBUTED TO INCIDENT. IN THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. THE POSSIBLE ROOT CAUSES 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 (E131106) 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).

    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 7TH OCTOBER, 2020 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. AS IT WAS STATED, UPPER JOINT COVER OF THE SPRING ARM 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 MIGHT CAUSE A CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138154 POWERLED LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD568330999

    Patients

    Seq Age Sex Outcome Treatment
    1