BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTIER SURGICAL TABLE

    MDR report key: 2435309 · Received January 18, 2012

    Report

    Report Number
    2031963-2012-00007
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Date of Event
    December 21, 2011
    Report Date
    December 21, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT INVOLVEMENT, THEREFORE NO PT DATA EXISTS. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. ACTUAL DEVICE WAS EVALUATED IN THE FIELD ON (B)(4), 2011. EVAL SUMMARY: AFTER AN ON-SITE EVAL BY A FIELD TECHNICIAN, IT WAS CONFIRMED THERE WAS A HYDRAULIC FLUID LEAK FROM THE SURGICAL TABLE. UPON FURTHER EVAL, THE TECHNICIAN IDENTIFIED THE SOURCE OF THE LEAK RESULTING FROM A MALFUNCTIONING SEAL IN ONE OF THE HYDRAULIC PUMPS. AT THE TIME OF THIS REPORT, THE SURGICAL TABLE IS OUT OF SERVICE AWAITING REPAIR. THIS MALFUNCTION POSES A RISK TO THE USER FOR A SLIPPING HAZARD FROM THE FLUID LEAK, AND IN ADDITION, IT POSES A RISK TO THE PT FOR THE INABILITY TO ARTICULATE THE TABLE, OR POTENTIALLY A DELAY TO MOVE THE PT OR STABILIZE THE TABLE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PT OR USER. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT THE VERTIER SURGICAL TABLE HAS A DAMAGED COLUMN CASING AND THE TABLE IS LEAKING HYDRAULIC FLUID. THERE WAS NO REPORT OF ANY PT INVOLVEMENT AND NO ADVERSE CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTIER SURGICAL TABLE FQO STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA