BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET EQUIPMENT

    MDR report key: 20037486 · Received August 22, 2024

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    Report

    Report Number
    9710055-2024-00480
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Report Date
    August 22, 2024
    Manufacturer
    MAQUET SAS
    Product Code
    FXR
    UDI-DI
    03700712416102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    PREVIOUS D1 BRAND NAME: EQT; CORRECTED D1 BRAND NAME: MAQUET EQUIPMENT; PREVIOUS D4 VERSION OF MODEL # ARD567712901; CORRECTED D4 VERSION OF MODEL # ARDSAT239020A; PREVIOUS D4 CATALOG # ARD567712901; CORRECTED D4 CATALOG # NONE; PREVIOUS D4 SERIAL # (B)(6); CORRECTED D4 SERIAL # (B)(6); PREVIOUS D4 UNIQUE IDENTIFIER (UDI) #: N/A; CORRECTED D4 UNIQUE IDENTIFIER (UDI) #: (B)(4). GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EQUIPMENT - XHSO. IT WAS STATED THE HANDLE FELL OFF FROM SCREEN HOLDER DURING OPERATION. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. BASED ON THE INFORMATION COLLECTED, 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. ACCORDING TO THE INFORMATION RECEIVED BY GETINGE, THE ISSUE OCCURRED DURING SURGERY. AS STATED BY THE SUBJECT MATTER EXPERT AT MANUFACTURING SITE, THE DETACHMENT BETWEEN HANDLE HOLDER AND ALUMINUM CYLINDER, WHICH ALLOWS BONDING OF THE HANDLE, IS PROBABLY DUE TO MECHANICAL SHOCKS, COLLISIONS OR EXCESSIVE EFFORTS. TO PREVENT ANY SIMILAR INCIDENT, THE FOLLOWING HAVE BEEN IMPLEMENTED: DURING THE MANUFACTURING THE PRATS 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. 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 31ST JULY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EQUIPMENT - XHSO. IT WAS STATED THE HANDLE FELL OFF FROM SCREEN HOLDER DURING OPERATION. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18002 MAQUET EQUIPMENT HOLDER, CAMERA, SURGICAL FXR MAQUET SAS ARDSAT239020A 03700712416102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown