BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXCEL

    MDR report key: 15949881 · Received December 9, 2022

    Report

    Report Number
    9710055-2022-00515
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    December 7, 2022
    Report Date
    December 9, 2022
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 7TH DECEMBER, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ AXCEL S. AS IT WAS STATED, THE PAINT WAS CHIPPING. 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. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 7TH DECEMBER, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ AXCEL S. AS IT WAS STATED, THE PAINT WAS CHIPPING FROM SPRING ARMS. 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. THE INITIAL REPORTER WAS GETINGE TECHNICIAN. QUOTE OF REPAIR DEVICE WAS SENT TO CUSTOMER, BUT CUSTOMER DID NOT ACCEPT IT. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION DUE TO PAINT CHIPPING, WHICH CONTRIBUTED TO THE EVENT. IT IS UNKNOWN IF THE DEVICE WAS OR WAS NOT BEING USED FOR A PATIENT¿S TREATMENT UPON THE EVENT OCCURRENCE. THE REVIEW OF RECEIVED CUSTOMER PRODUCT COMPLAINTS RELATED TO THE INVESTIGATED ISSUE REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. ACCORDING TO THE SUBJECT MATTER EXPERT AT THE MANUFACTURING SITE, IT WAS CONCLUDED THAT THE MANUFACTURER 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. 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.

    Description of Event or Problem · 0

    ON (B)(6)2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ AXCEL S. AS IT WAS STATED, THE PAINT WAS CHIPPING. 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

    ON 7TH DECEMBER, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ AXCEL S. AS IT WAS STATED, THE PAINT WAS CHIPPING FROM SPRING ARMS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2571838 AXCEL LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD567501965

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown