BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHASTAR MOBILE OPERATING TABLE

    MDR report key: 7909448 · Received September 26, 2018

    Report

    Report Number
    8010652-2018-00023
    Event Type
    Malfunction
    Date Received
    September 26, 2018
    Date of Event
    August 28, 2018
    Report Date
    September 25, 2018
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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). PICTURES FROM THE TABLE IN QUESTION WERE PROVIDED BY THE CUSTOMER. THE PICTURES SHOW A BREAK AT THE JOINTS OF THE LEG PLATE PART OF THE TABLE TOP. FURTHER THE CUSTOMER INFORMED US THAT THE WHOLE PATIENT WAS POSITIONED ON THE LEG PLATE PART OF THE TABLE TOP TO PERFORM A UROLOGY SURGERY. IN THE INSTRUCTIONS FOR USE OF THE PRODUCT IT IS STATED THAT FOR THESE KINDS OF SURGERIES THE LEG PLATE HAS TO BE BEND DOWN AND THE PATIENT HAS TO BE POSITIONED ON THE BACK PLATE. THIS WAY THE CENTER OF GRAVITY OF THE PATIENT IS LOCATED ABOVE THE COLUMN OF THE OPERATING TABLE AND NO HIGH FORCES ARE EXERTED TO THE JOINTS OF THE TABLE TOP. WE ASSUME THAT THE TABLE TOP / THE LEG PLATE PART WAS PRE-DAMAGED DUE TO COLLISION(S) IN THE COURSE OF TIME. SUCH COLLISION(S) MAY BUT DO NOT NECESSARILY LEAD TO AN IMMEDIATE MALFUNCTION OF THE LEG PLATE. THE LEG PLATE MAY ONLY BE PRE-DAMAGED AND BROKE AT LEAST AT THIS CASE. IN THE INSTRUCTIONS FOR USE IT IS STATED THAT THE USER MUST CONSTANTLY OBSERVE THE OPERATING TABLE AND THE ACCESSORIES DURING ADJUSTMENT IN ORDER TO AVOID COLLISIONS. THE TABLE IN QUESTION WAS MANUFACTURED IN 2000 AND HAS BEEN IN CLINICAL USE FOR OVER 17 YEARS. GETINGE - MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    WE WERE INFORMED BY THE CLINIC THAT AT THE BEGINNING OF A PROCEDURE THE LEG PLATE OF THE OPERATING TABLE BROKE AND THE PATIENT FELL FROM THE TABLE. NO INJURY HAS BEEN REPORTED TO GETINGE - MAQUET. THE PATIENT WAS TRANSFERRED TO ANOTHER TABLE AND THE PROCEDURE WAS PERFORMED WITHOUT ANY COMPLICATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752087 ALPHASTAR MOBILE OPERATING TABLE TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 113201A0

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other