BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEERA EU WITHOUT AUTO DRIVE

    MDR report key: 12630110 · Received October 14, 2021

    Report

    Report Number
    8010652-2021-00029
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    October 12, 2021
    Report Date
    November 10, 2021
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE-MAQUET FIELD SERVICE ENGINEER HAS INVESTIGATED THE AFFECTED TABLE AND HAS NOT FOUND ANY DAMAGE OR MALFUNCTION. 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

    MANUFACTURER REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    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 TO US. DURING A SURGERY A PART OF THE TABLES BASE WAS LIFTED OFF THE FLOOR. A NURSE STUCK HER FOOT IN THE GAP BETWEEN FLOOR AND OR TABLE. NEXT THE TABLES' BASE FELL DOWN ON THE FLOOR. THE NURSE WAS INJURED AND RECEIVED A FRACTURE ON ONE OF THE TOES. MANUFACTURER REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527611 MEERA EU WITHOUT AUTO DRIVE TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 720001B0 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other