BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SST (500 LBS.) W/GIMBALS & SHEARGUARD GEL PADS W/MODULAR CART

    MDR report key: 3246629 · Received January 28, 2013

    Report

    Report Number
    2921578-2013-00001
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 9, 2013
    Report Date
    December 28, 2012
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE USE OF THE SPINAL TABLE, THE FOOT OF THE TABLE FELL FROM THE TABLE AND LANDED ON THE FLOOR. THE PT WAS ON THE TABLE, BUT THE PT WAS NOT INJURED, AND THE PT'S HEAD REMAINED STABLE THROUGHOUT THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38713 SST (500 LBS.) W/GIMBALS & SHEARGUARD GEL PADS W/MODULAR CART TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JEA MIZUHO OSI 5943 5943

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other