BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHASTAR PRO, EU, SFC, LOW

    MDR report key: 8390211 · Received March 5, 2019

    Report

    Report Number
    8010652-2019-00009
    Event Type
    Injury
    Date Received
    March 5, 2019
    Date of Event
    February 21, 2019
    Report Date
    March 5, 2019
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET GMBH, KEHLER STRASSE 31, RASTATT, GERMANY 76437. EXEMPTION # E2018004. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). NO MALFUNCTION OF THE PRODUCT WAS REPORTED BY THE CUSTOMER. A GETINGE - MAQUET SERVICE ENGINEER VISITED THE CLINIC, CHECKED THE AFFECTED TABLE AND CONFIRMED THAT THE TABLE WORKED ACCORDING TO SPECIFICATION. THE INCIDENT WAS CAUSED BY USER ERROR. IN THE INSTRUCTIONS FOR USE (IFU) IT IS STATED THE USER IS 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, COLLISIONSMAY 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." "WARNING! RISK OF INJURY! WHEN ADJUSTING, MOVING OR STORING THE OR TABLE / TABLE TOP, THE STAFF, THE PATIENT AND THE ACCESSORIES ARE EXPOSED TO PINCHING AND SHEARING HAZARDS, PARTICULARLY IN THE AREA AROUND THE JOINTS AT THE HEAD, BACK AND LEG PLATES. ALWAYS ENSURE THAT NO ONE CAN BE SUBJECTED TO PINCHING OR SHEARING ACTION OR INJURED IN ANY OTHER WAY AND THAT THE ACCESSORIES DO NOT COLLIDE WITH ANY NEARBY OBJECTS." MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A DOCTOR BROKE HIS RIGHT TOE WHILE USING THE OPERATING TABLE. THE LEG PLATES OF THE TABLE POINTED DOWNWARDS IN AN 90° ANGLE AND THE TABLE WAS LOWERED. THE LEG PLATES TOUCHED THE GROUND AND WHEN THE TABLE WAS LOWERED FURTHER THE MOVEMENT WAS BLOCKED BY THE LEG PLATES. AS A RESULT THE TABLE WAS LIFTED OFF THE FLOOR. THE DOCTOR'S RIGHT TOE GOT UNDER THE TABLE. THE LEG PLATES WERE MOVED AND THE TABLE HIT THE GROUND. THE DOCTOR'S RIGHT TOE WHICH WAS UNDER THE TABLE GOT PINCHED AND HIS RIGHT TOE GOT BROKEN (BONE BROKE). MANUFACTURER REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182737 ALPHASTAR PRO, EU, SFC, LOW TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 113222B0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other