BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G8 G8E

    MDR report key: 16493845 · Received March 7, 2023

    Report

    Report Number
    9710055-2023-00175
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 20, 2023
    Report Date
    March 7, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORTER WAS GETINGE TECHNICIAN. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER WAS GETINGE TECHNICIAN. THE CORRECTION OF D4 VERSION OR MODEL # DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D4 VERSION OR MODEL #ARD568121111C. CORRECTED D4 VERSION OR MODEL # ARD568102997. THE CORRECTION OF D5 CATALOG # DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D5 CATALOG #ARD568121111C. CORRECTED D5 CATALOG # ARD568102997. THE CORRECTION OF H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE - EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER: NO. CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: N/A. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - G8G8E. AS IT WAS STATED, UPON THE DEVICE INSPECTION FIVE OUT OF THE SIX FIXATION SCREWS HOLDING THE DEVICE MAIN TUBE WERE LOOSE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS LOOSE SCREWS HOLDING THE DEVICE CONFIGURATION MAY LEAD TO THE DEVICE DETACHMENT FROM THE CEILING AND 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 GATHERED, THE ISSUE WAS DISCOVERED DURING INSPECTION BY GETINGE. A ROOT CAUSE ANALYSIS WAS CONDUCTED BY THE SUBJECT MATTER EXPERT. ACCORDING TO THE ANALYSIS THERE ARE TWO PROBABLE SCENARIOS. IN CASE OF LOOSENING, THE PROBABLE CAUSES OF LOOSENING CORRESPONDS TO AN IMPROPER INITIAL TIGHTENING DURING THE INSTALLATION OR MAINTENANCE NOT IN ACCORDANCE WITH THE MANUFACTURER'S RECOMMENDATIONS. IN CASE OF RUPTURE, THE FAILURE OF THE SCREWS IS RELATED TO FATIGUE STRESSES DUE TO MODERATE SHEAR OVERLOAD. ALL FACIES HAVE A FATIGUE FAILURE ZONE MORE OR LESS EXTENSIVE. INITIATED AT THE BOTTOM OF THE THREAD, THE REPEATED LOW MECHANICAL STRESSES CAUSED THE BREAKAGE OF THE FIRST SCREW. THE RUPTURE OF THE OTHER SCREWS CORRESPONDS TO PROGRESSIVE PROPAGATION OF THE SHEAR EFFECT. TO PREVENT ANY INCIDENT THE YEARLY PREVENTIVE MAINTENANCE PROGRAM, MENTIONS TO CHECK THE SUSPENSION FIXING SCREWS. IT IS ALSO INDICATED TO NOT RETIGHTEN THE SCREWS DURING MAINTENANCE. IF SCREWS APPEAR LOOSENED, REPLACE THEM. IT IS ALSO STATED TO REPLACE THE 6 FIXING SCREWS EVERY 6 YEARS. IN APRIL 2019 GETINGE TRANSMITTED THE SERVICE BULLETIN 98A ON GETINGE ONLINE REMINDING TO CARRY OUT PREVENTIVE MAINTENANCE AND WEARING PARTS REPLACEMENT TO ENSURE THE DEVICE SAFETY, THE SERVICE BULLETIN 98A MENTIONS TO REPLACE THE SUSPENSION FIXING SCREWS EVERY 6 YEARS DURING THE PREVENTIVE MAINTENANCE.

    Description of Event or Problem · 0

    ON 20TH FEBRUARY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - G8G8E. AS IT WAS STATED, UPON THE DEVICE INSPECTION FIVE OUT OF THE SIX FIXATION SCREWS HOLDING THE DEVICE MAIN TUBE WERE LOOSE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS LOOSE SCREWS HOLDING THE DEVICE CONFIGURATION MAY LEAD TO THE DEVICE DETACHMENT FROM THE CEILING AND 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
    706108 G8 G8E LAMP, SURGICAL FTD MAQUET SAS ARD568102997

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown