BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RITTER

    MDR report key: 1867754 · Received October 6, 2010

    Report

    Report Number
    1523530-2010-00010
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 8, 2010
    Report Date
    October 5, 2010
    Manufacturer
    MIDMARK CORP.
    Product Code
    GBB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXAM TABLE WAS EXAMINED BY AN INDEPENDENT SERVICE TECH. THE DEVICE WAS INSPECTED AND FOUND TO BE FUNCTIONING AS INTENDED. THE SERVICE TECH BELIEVES THE BACK OF THE DEVICE WAS CONTACTING THE WALL. IF THE BACK OF A TABLE IS IN CONTACT WITH THE WALL, THE BACK WILL RAISE BY THE CYLINDER ALL THE WAY UP, BUT WHEN LOWERED, IT CONTACTS THE WALL ON THE WAY DOWN AND MAY STOP VIA FRICTION FROM THE WALL. THE CYLINDER CONTINUES TO LOWER TO ITS LOWEST MOST POINT, AND THE BACK IS STILL RAISED APPROX 2-3". THE BACK WILL THEN DROP TO THE LOWEST MOST POSITION IF PRESSURE IS APPLIED.

    Description of Event or Problem · 1

    BIOMED STATED TABLE WAS 1/2 WAY UP WITH PT ON TABLE -TABLE DROPPED. THIS IS THE 2ND TIME THIS OCCURRED. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RITTER CHAIR, SURGICAL, AC-POWERED GBB MIDMARK CORP. 223-016

    Patients

    Seq Age Sex Outcome Treatment
    1