BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON

    MDR report key: 3040999 · Received August 25, 2006

    Report

    Report Number
    1825014-2006-00007
    Event Type
    Malfunction
    Date Received
    August 25, 2006
    Report Date
    August 7, 2006
    Manufacturer
    SKYTRON A DIVISION OF KNW GROUP
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRELIMINARY REVIEW OF THE KIDNEY BRIDE INVOLVED IN THE INCIDENT REVEALED NO ABNORMAL STRESS CRACKS OR DEFECTS IN THE MATERIAL. THEREFORE, THE CAUSE OF THE INCIDENT IS UNK AT THIS TIME. SKYTRON WILL BE FILING THE REQUIRED FOLLOW-UP REPORT WITH THE HOSPITAL CONTACT INDIVIDUAL AND MANUFACTURER IN AN EFFORT TO ARRIVE AT A CONCLUSION AND DETERMINE THE CASE OF THE FAILURE. WE WILL REQUEST THE MANUFACTURER PERFORM TESTS TO ACHIEVE A CONCLUSION AS TO THE CAUSE OF THIS INCIDENT.

    Description of Event or Problem · 1

    WHEN PT WAS BEING LIFTED THE PLEXIGLASS KIDNEY BRIDGE BROKE IN HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYTRON SURGICAL TABLE GDC SKYTRON A DIVISION OF KNW GROUP 6002 A0034

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention