BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQT

    MDR report key: 20085446 · Received August 28, 2024

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    Report

    Report Number
    9710055-2024-00492
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 19, 2024
    Report Date
    August 28, 2024
    Manufacturer
    MAQUET SAS
    Product Code
    FXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE AS THIS MEDICAL DEVICE/MODEL WAS MARKETED AND/OR DISCONTINUED IN US BEFORE THE UDI REQUIREMENT BECAME MANDATORY. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM, H6 INVESTIGATION FINDINGS AND H6 INVESTIGATION CONCLUSIONS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 19TH AUGUST 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - XD DUAL FLAT SCREEN. IT WAS STATED THE COVER PLATES WERE MISSING FROM DEVICE. 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. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 19TH AUGUST 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - XD DUAL FLAT SCREEN. IT WAS STATED THE COVER PLATES WERE MISSING FROM DEVICE. 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. THE INCIDENT WAS INITIALLY ASSESSED AS REPORTABLE, AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. RECENTLY, THE INCIDENT HAS BEEN REEVALUATED AS ACCORDING TO THE SUBJECT MATTER EXPERT, THERE IS NO ALLEGATION OR EVIDENCE OF A FALL-OFF OR UNINTENTIONAL DETACHMENT OF PARTS REPLACED. THESE MISSING PARTS DO NOT AFFECT THE SAFE OR EFFECTIVE OPERATION OF THE DEVICE AND DO NOT LEAD TO ADVERSE HEALTH OUTCOMES FOR PATIENT SAFETY. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE. PREVIOUS H6 INVESTIGATION FINDINGS: RESULTS PENDING COMPLETION OF INVESTIGATION 3233. CORRECTED H6 INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND 213. PREVIOUS H6 INVESTIGATION CONCLUSIONS: CONCLUSION NOT YET AVAILABLE 11. CORRECTED H6 INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED 67. INITIALLY PROVIDED INFORMATION WAS POINTING TO MISSING COVER PLATES. THE ISSUE IS CONSIDERED AS SAFETY RELATED AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. ACCORDING TO ADDITIONAL CLARIFICATION PROVIDED BY THE SUBJECT MATTER EXPERT, INITIAL INFORMATION WAS INCORRECT. IT WAS DETERMINED THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED AS THERE WAS NO ALLEGATION OR EVIDENCE OF A FALL OFF OR UNINTENTIONAL DETACHMENT OF PARTS THAT HAVE BEEN REPLACED. THE INVESTIGATION WAS PERFORMED. THE INVESTIGATED SCENARIOS DID NOT CAUSE RISK TO HUMAN LIFE. THE REVIEW OF THE CUSTOMER PRODUCT COMPLAINTS, RELATED TO INVESTIGATED ISSUE IN TIME, SHOWS THAT THERE IS NO REGULAR INCOME. THERE IS NO INDICATION IF THE DEVICE WAS BEING USED FOR PATIENT TREATMENT AT THE TIME WHEN THE EVENT OCCURRED. NO APPARENT REASON WAS IDENTIFIED FOR SUGGESTING OPENING A CAPA OR EVALUATION FOR THE NEED OF ANOTHER ACTION IN THE MARKET.

    Description of Event or Problem · 0

    ON 19TH AUGUST 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT: XD DUAL FLAT SCREEN. IT WAS STATED THE COVER PLATES WERE MISSING FROM DEVICE. 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

    ON 19TH AUGUST 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - XD DUAL FLAT SCREEN. IT WAS STATED THE COVER PLATES WERE MISSING FROM DEVICE. 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. THE INCIDENT WAS INITIALLY ASSESSED AS REPORTABLE, AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. RECENTLY, THE INCIDENT HAS BEEN REEVALUATED AS ACCORDING TO THE SUBJECT MATTER EXPERT, THERE IS NO ALLEGATION OR EVIDENCE OF A FALL-OFF OR UNINTENTIONAL DETACHMENT OF PARTS REPLACED. THESE MISSING PARTS DO NOT AFFECT THE SAFE OR EFFECTIVE OPERATION OF THE DEVICE AND DO NOT LEAD TO ADVERSE HEALTH OUTCOMES FOR PATIENT SAFETY. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127389 EQT HOLDER, CAMERA, SURGICAL FXR MAQUET SAS ARD567701940

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown