BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREEN HOLDER

    MDR report key: 11841638 · Received May 18, 2021

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    9710055-2021-00194
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    May 12, 2021
    Report Date
    July 7, 2021
    Manufacturer
    MAQUET SAS
    Product Code
    FXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH SCREEN HOLDER. THE HANDLE SUPPORT HAS DETACHED. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF MAY CAUSE POTENTIAL INFECTION. THE PROBLEM WAS SOLVED BY REPLACING THE DEFECTIVE PART. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE EVENT. AT THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS NOT BEING USED FOR THE PATIENT TREATMENT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE TYPE, WE HAVE BEEN ABLE TO CONFIRM THAT THE INVESTIGATED ISSUE HAS NEVER LED TO SERIOUS INJURY OR WORSE, TO OUR KNOWLEDGE. THE DETACHMENT BETWEEN ALUMINUM CYLINDER AND THE HANDLE SUPPORT IS PROBABLY DUE TO MECHANICAL SHOCK, COLLISIONS OR EXCESSIVE EFFORTS. TO PREVENT ANY SIMILAR INCIDENT: - DURING THE MANUFACTURING THE PARTS ARE DEGREASED; - THE QUANTITY OF THE INSTANT ADHESIVE GEL DEPOSITED IS CHECKED; - THE ADHESIVE BONDING IS CHECKED BY MANUAL TRACTION DURING THE MANUFACTURING; - THE USER MANUAL #0421101 XS/XD FLAT SCREEN MONITORS HOLDERS MENTIONS TO CHECK THE CONDITION OF THE STERILIZABLE HANDLE. WE BELIEVE THAT ALL REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. GIVEN THE CIRCUMSTANCES AND AFTER OUR REVIEW OF COMPLAINT RATIO BEHAVIOR OF THIS NATURE, 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'S 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 13TH MAY, 2021 GETINGE BECAME AWARE OF AN ISSUE WITH SCREEN HOLDER. THE HANDLE SUPPORT HAS DETACHED. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF MAY CAUSE POTENTIAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740569 SCREEN HOLDER HOLDER, CAMERA, SURGICAL FXR MAQUET SAS ARD567711910

    Patients

    Seq Age Sex Outcome Treatment
    1