BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBL COMPONENT, BASIC TABLE WITH SEAT SECTION

    MDR report key: 1830042 · Received September 7, 2010

    Report

    Report Number
    2031963-2010-00114
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    June 21, 2010
    Report Date
    June 21, 2010
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FQO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT, THUS NO PT DATA EXISTS. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. ACTUAL DEVICE WAS EVALUATED IN THE FIELD ON (B)(4) 2010. EVAL SUMMARY: AFTER EVAL BY THE FIELD SERVICE TECHNICIAN, IT WAS FOUND THAT ONE OF THE FLOOR LOCK CYLINDERS WAS LEAKING. THE TABLE WAS RETURNED TO STRYKER TO REPLACE THE FLOOR LOCK CYLINDER. THE ROOT CAUSE FOR THIS FAILURE IS POSSIBLY DUE TO WORN OUT USIT WASHERS. THIS TYPE OF MALFUNCTION POSES A MODERATE RISK TO A USER FOR CAUSING A POTENTIAL SLIPPING HAZARD. OR IF A LEAK WAS NOT NOTICED, IT CAN LEAD TO COMPLETE HYDRAULIC FLUID DRAIN CAUSING THE TABLE TO BE COMPLETELY NON-FUNCTIONAL FOR ARTICULATIONS (EXCEPT FOR SLIDE MECHANISM). HOWEVER, THIS SPECIFIC MALFUNCTION WAS IDENTIFIED PRIOR TO USE AND NO PTS WERE INVOLVED AND NO ADVERSE EVENTS WERE REPORTED. THIS TYPE OF NON-CONFORMANCE WILL BE MONITORED FOR ADVERSE TRENDS. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT THE SURGICAL TABLE IN OR3 HAS A BROKEN FOOT BRAKE AND CANNOT LOCK THE TABLE AND MOVE FREELY. UPON FURTHER EVALUATION OF THE FLOOR LOCKS, ONE FLOOR LOCK CYLINDER WAS FOUND TO BE LEAKING. THERE WAS NO REPORTED PT INVOLVEMENT, AND NO REPORTED ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TBL COMPONENT, BASIC TABLE WITH SEAT SECTION FQO STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA