BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEERA EU WITH AUTO DRIVE

    MDR report key: 11655697 · Received April 13, 2021

    Report

    Report Number
    3013876692-2021-00025
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    April 4, 2021
    Report Date
    October 12, 2021
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE-MAQUET FIELD SERVICE ENGINEER HAS INVESTIGATED THE AFFECTED TABLE AND HAS NOT FOUND ANY DAMAGE OR MALFUNCTION. FURTHER INFORMATION CONCERNING THIS INCIDENT WAS REQUESTED FROM THE CLINIC, BUT NOT PROVIDED. WE ASSUME THAT THE FOLLOWING HAS HAPPENED. THE TABLES' DOWNWARD MOVEMENT WAS BLOCKED BY AN OBSTACLE, E.G. AN INSTRUMENT TABLE. WHEN THE TABLE OR A PART OF IT WAS MOVED DOWNWARDS, THE TABLES BASE WAS LIFTED OF THE FLOOR. ONCE THE OBSTACLE BROKE OR SLIPPED OUT, THE TABLES BASE WAS LOWERED BACK ON THE FLOOR AND CRUSHED THE DOCTORS FOOT. IN THE INSTRUCTIONS FOR USE (IFU) IT IS STATED THE USER HAS TO PAY ATTENTION AND AVOID COLLISIONS WHEN OPERATING THE TABLE. IN CHAPTER 2 OF THE IFU POSSIBLE HAZARDS ARE STATED: "WARNING! RISK OF INJURY! WHEN ADJUSTING AND MOVING THE OR TABLE, THE TABLE TOP OR THE ACCESSORIES, COLLISIONS MAY OCCUR WITH THE PATIENT, BETWEEN THE INDIVIDUAL PRODUCTS OR PARTS POINTING DOWNWARDS. DURING THE ADJUSTMENT PROCEDURES, ALWAYS PAY ATTENTION TO THE OR TABLE AND ACCESSORIES AND AVOID COLLISIONS. ENSURE THAT TUBES, CABLES AND DRAPES ARE NOT TRAPPED." GETINGE-MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    THE CLINIC STATED THAT THE TABLE WAS DRIVEN INTO THE TRENDELENBURG POSITION WHEN THE ISSUE OCCURRED. AN X-RAY WAS TAKEN OF THE INJURED FOOT. NO BROKEN BONES WERE FOUND DUE TO THIS ACCIDENT. THE SURGEON GOT SOME PAINKILLER. NO MAYOR DELAY OF THE SURGERY HAS OCCURRED. MANUFACTURER REFERENCE# (B)(4).

    Additional Manufacturer Narrative · 1

    A GETINGE-MAQUET FIELD SERVICE ENGINEER HAS INVESTIGATED THE AFFECTED TABLE AND HAS NOT FOUND ANY DAMAGE OR MALFUNCTION. AT THE TIME OF THIS REPORT THE INVESTIGATION IS STILL ONGOING. WHEN THE INVESTIGATION IS COMPLETE THE REPORT WILL BE UPDATED AND A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED. THE PATIENT WAS ON THE TABLE WHEN THE TABLE WAS LOWERED AS REQUESTED. THE CUSTOMER DESCRIBED THAT THE TABLE "JOLTED" AND A PART OF THE TABLES BASE FELL ON THE LEFT FOOT OF A SURGEON. THIS CAUSED AN INJURY. WE HAVE REQUESTED FURTHER INFORMATION CONCERNING THE INCIDENT AND THE EXTENT OF THE INJURY, BUT NOT RECEIVED IT YET. MANUFACTURER REFERENCE# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552218 MEERA EU WITH AUTO DRIVE TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 720001B2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other