BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEERA EU WITH AUTO DRIVE

    MDR report key: 10874299 · Received November 20, 2020

    Report

    Report Number
    8010652-2020-00025
    Event Type
    Injury
    Date Received
    November 20, 2020
    Date of Event
    November 13, 2020
    Report Date
    January 22, 2021
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IN THE MEANTIME WE WERE INFORMED BY THE CUSTOMER THAT IN ADDITION TO THE INJURED FOOT OF THE DOCTOR, THE ACTUAL SURGERY OF THE PATIENT WAS DELAYED FOR APPROXIMATELY 1 HOUR DUE TO THE INCIDENT. MANUFACTURER REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    NO MALFUNCTION OF THE PRODUCT WAS REPORTED BY THE CUSTOMER. THE INCIDENT WAS CAUSED BY A USER ERROR. THE CUSTOMER MADE A FUNCTIONAL CHECK OF THE TABLE AFTER THE PROCEDURE AND NO MALFUNCTION WAS DETECTED. 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 · 1

    THE FOLLOWING APPEARS TO HAVE HAPPENED AND WAS REPORTED TO US. THE TABLE TOP OF THE USED OR TABLE CAN BE LOWERED. IN THIS CASE THE DOWNWARD MOVEMENT OF THE OR TABLE TOP WAS BLOCKED BY AN INSTRUMENT TROLLEY AND THE OR TABLES BASE WAS LIFTED FROM THE GROUND WHICH WAS NOT RECOGNIZED BY THE USER. IT WAS DESCRIBED THAT THE OR TABLE WAS ¿ROCKING¿. THE MEDICAL STAFF STABILIZED THE PATIENTS POSITION ON THE TABLE TOP. AT SOME POINT A SURGEON PUT HER FOOT UNDER THE LIFTED TABLE BASE. WHEN THE TABLE TOP WAS RAISED, THE TABLE BASE WAS LOWERED ON THE DOCTORS FOOT. THE SURGEON INJURED HER FOOD AND ATTENDED THE ACCIDENT AND EMERGENCY DEPARTMENT. SHE HAD TWO BROKEN BONES IN HER FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343368 MEERA EU WITH AUTO DRIVE TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 720001B2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other