BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBL PACKAGE, BASIC ASSEMBLY IN CRATE

    MDR report key: 2104847 · Received May 17, 2011

    Report

    Report Number
    2031963-2011-00033
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NEW PARTS INSTALLED (B)(4) 2011. THE MANUFACTURER DATE OF THE DEVICE WAS UNKNOWN AT THE TIME OF THIS REPORT. EVALUATION SUMMARY: THE VERTIER MOBILE SURGICAL OPERATING TABLE IS A CLASS I, TYPE B DEVICE USED BY SURGICAL STAFF TO POSITION AND SUPPORT A PATIENT FOR SURGICAL PROCEDURES IN A HOSPITAL OPERATING ROOM. THE COMPLAINT WILL BE FILED AS A MDR DUE TO HYDRAULIC FLUID LEAKAGE FROM FAILED HYDRAULIC CYLINDERS. THE ROOT CAUSE FOR THIS FAILURE IS POSSIBLY DUE TO WORN OUT (B)(4) WASHERS. ANY HYDRAULIC LEAK WOULD NOT CONTRIBUTE TO PATIENT RISK DIRECTLY. HOWEVER, HYDRAULIC LEAK CAN CAUSE A SLIPPERY OPERATING ROOM WHICH CAN BE A POTENTIAL FOR USER INJURY DURING OR AFTER SURGERY. ALSO, THE HYDRAULIC LEAK IF UNNOTICED CAN LEAD TO COMPLETE HYDRAULIC FLUID DRAIN CAUSING THE TABLE TO BE COMPLETELY NON-FUNCTIONAL FOR ARTICULATIONS (EXCEPT FOR SLIDE MECHANISM). THIS RISK IS MUCH MORE REMOTE THAN THE SLIPPAGE RISK, WHICH HAS OCCURRED.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT A VERTIER SURGICAL TABLE HAS A FLOOR LOCK CYLINDER THAT WAS LEAKING HYDRAULIC FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TBL PACKAGE, BASIC ASSEMBLY IN CRATE FQO STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA