BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET OR TABLE SYSTEM ALPHAMAQUET

    MDR report key: 6987703 · Received October 30, 2017

    Report

    Report Number
    8010652-2017-00014
    Event Type
    Injury
    Date Received
    October 30, 2017
    Date of Event
    October 2, 2017
    Report Date
    October 30, 2017
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IN QUESTION WAS INVESTIGATED BY (B)(4) - MAQUET SERVICE TECHNICIANS ON 2017-10-03. DURING THE INVESTIGATION NO MALFUNCTION WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND NO DEVIATION COULD BE DETECTED. ALL INVOLVED PRODUCTS WORKED AS SPECIFIED. WE ASKED THE CUSTOMER SEVERAL TIMES REGARDING THE OUTCOME OF THE PATIENT BUT JUST GOT THE REPLY THAT THIS KIND OF INFORMATION IS CONFIDENTIAL. (B)(4) - MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT AT THE END OF A PROCEDURE THE TABLE TILTED UNINTENTIONALLY AND THE PATIENT FELL FROM THE TABLE AND INJURED HIS HEAD. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767598 MAQUET OR TABLE SYSTEM ALPHAMAQUET TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 115002A0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other