BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET MOBILE OPERATION ROOM TABLE ALPHAMAXX

    MDR report key: 4101631 · Received August 27, 2014

    Report

    Report Number
    8010652-2014-00016
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 11, 2014
    Manufacturer
    MAQUET GMBH
    Product Code
    FQO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE DESCRIPTION OF THE HOSPITAL THERE WAS NO MALFUNCTION OF THE DEVICE. BASED UPON THE CUSTOMER'S DESCRIPTION, MAQUET BELIEVES USER ERROR IS THE ROOT CAUSE OF THE EVENT. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    ON REQUEST OF THE SURGEON, THE OPERATING TABLE WAS BEING ADJUSTED AND THE TABLE LOWERED. THE EDGE OF THE TABLE LOWERED ONTO THE HEIGHT ADJUSTMENT KNOB OF A MAYO INSTRUMENT TRAY WHICH WAS POSITIONED UNDER THE TABLETOP. AS THE TABLE CONTINUED TO BE LOWERED, THE BASE OF THE OPERATING TABLE LIFTED OFF THE GROUND. THE COMBINED LOAD OF THE TABLE AND PATIENT SHEERED THE ADJUSTMENT KNOB OFF OF THE ACCESSORY TRAY AND THE TABLE FELL TO THE GROUND, TRAPPING THE ASSISTANT SURGEON'S FOOT UNDER THE SUPPORT PLINTH. AS A RESULT, ONE OF THE SURGEON'S TOES WAS BLEEDING AND THE NAIL DETACHED. NO INJURY TO THE PATIENT WAS REPORTED TO MAQUET. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522793 MAQUET MOBILE OPERATION ROOM TABLE ALPHAMAXX TABLE, OPERATING-ROOM, AC-POWERED FQO MAQUET GMBH 1133.02B2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI