BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XD DUAL FLAT SCREEN (24) HOLDER

    MDR report key: 16750966 · Received April 17, 2023

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    Report

    Report Number
    9710055-2023-00309
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    April 12, 2023
    Report Date
    April 17, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE REPORTING TIMEFRAME WE WOULD LIKE TO PROVIDE THE INFORMATION ABOUT CURRENT STATUS OF THE ISSUE. PLEASE BE ADVISED THAT IT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 12TH APRIL, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. IT WAS STATED THE MONITOR HANDLE HOLDER CAME OFF FROM THE MONITOR. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 12TH APRIL, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EQUIPMENT - XD DUAL FLAT SCREEN (24) HOLDER. IT WAS STATED THE MONITOR HANDLE HOLDER CAME OFF FROM THE MONITOR. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY. THE CORRECTION OF D1 BRAND NAME AND D2A PRODUCT CODE DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D1 BRAND NAME: POWERLED. CORRECTED D1 BRAND NAME: XD DUAL FLAT SCREEN (24) HOLDER. PREVIOUS D2A PRODUCT CODE: FSY. CORRECTED D2A PRODUCT CODE: FXR.

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EQUIPMENT - XD DUAL FLAT SCREEN (24) HOLDER. IT WAS STATED THE MONITOR HANDLE HOLDER CAME OFF FROM THE MONITOR. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, MAQUET EQUIPMENT DID NOT MEET ITS SPECIFICATION, DUE HANDLE HOLDER WHICH CAME OFF FROM THE MONITOR. SUCH A SCENARIO COULD BE CONSIDERED AS TECHNICAL DEFICIENCY, AND IN THIS WAY THE DEVICE CONTRIBUTED TO THE EVENT. PROVIDED INFORMATION DOES NOT INDICATE IF UPON THE EVENT OCCURRENCE, THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE TYPE, IT WAS CONFIRMED THAT IN THE LAST 5 YEARS, REGISTERED FOR THE ISSUE OF HANDLE HOLDER DETACHMENT ON MAQUET EQUIPMENT THERE WAS NO SERIOUS INJURY OR WORSE REPORTED. 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 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 (IFU 01821 EN 11) ON PAGES 35 AND 40 MENTIONS TO CHECK THE CONDITION OF THE STERIZABLE HANDLE. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER¿S RECOMMENDATION HAD BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. EVENT SITE NAME: (B)(6). H3 OTHER TEXT: DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    ON 12TH APRIL, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EQUIPMENT - XD DUAL FLAT SCREEN (24) HOLDER. IT WAS STATED THE MONITOR HANDLE HOLDER CAME OFF FROM THE MONITOR. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ON 12TH APRIL, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED. IT WAS STATED THE MONITOR HANDLE HOLDER CAME OFF FROM THE MONITOR. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053870 XD DUAL FLAT SCREEN (24) HOLDER HOLDER, CAMERA, SURGICAL FXR MAQUET SAS ARD567701940
    1827340 XD DUAL FLAT SCREEN (24) HOLDER HOLDER, CAMERA, SURGICAL FXR MAQUET SAS ARD567701940

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown