BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XS SINGLE FLAT SCREEN HOLDER

    MDR report key: 19653255 · Received July 2, 2024

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    Report

    Report Number
    9710055-2024-00394
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 18, 2024
    Report Date
    July 2, 2024
    Manufacturer
    MAQUET SAS
    Product Code
    FXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SITE NAME: (B)(6). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER FOR THE MEDICAL DEVICE REFERRED TO IN THIS MEDICAL DEVICE REPORT HAS NOT BEEN RECEIVED, AND THEREFORE, NO UDI NUMBER CAN BE PROVIDED. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - XS SINGLE FLAT SCREEN HOLDER. IT WAS STATED THAT THERE WAS A SIGNIFICANT LOSS OF PAINT ON THE DISC DUE TO THE MOVEMENT OF THE DISC. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES 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 AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. THE CLAIMED DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERT AT MANUFACTURER¿S. THE ANALYSIS IS FOLLOWING: WITHOUT PICTURES REQUIRED IT IS NOT POSSIBLE TO FIND OUT THE ROOT CAUSE. MAQUET DID NOT RECEIVE ENOUGH INFORMATION TO CONDUCT THE TECHNICAL INVESTIGATION. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE NOR PROVIDE THE MOST PROBABLE ROOT CAUSES. IN CASE OF NEW RELEVANT INFORMATION, THE CASE WILL BE RECONSIDERED. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 0

    ON 18TH JUNE, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - XS SINGLE FLAT SCREEN HOLDER. IT WAS STATED THAT THERE WAS A SIGNIFICANT LOSS OF PAINT ON THE DISC DUE TO THE MOVEMENT OF THE DISC. THERE WAS NO INJURY REPORTED, HOWEVER, 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
    570893 XS SINGLE FLAT SCREEN HOLDER HOLDER, CAMERA, SURGICAL FXR MAQUET SAS EQT - OTHER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown