BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 756405 · Received August 11, 2006

    Report

    Report Number
    756405
    Event Type
    Malfunction
    Date Received
    August 11, 2006
    Date of Event
    July 21, 2006
    Report Date
    August 11, 2006
    Manufacturer
    SKYTRON, DIVISION OF KMW GROUP
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AT THE BEGINNING OF THE OPERATION, THE PATIENT WAS NOT ABLE TO BE POSITIONED CORRECTLY (TOP TO SLIDE TOWARD THE FOOT TO ACCOMMODATE C-ARM USE), SO THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER OR TABLE. THE UNIT WAS SENT TO BIOMEDICAL ENGINEERING WHERE IT WAS DISCOVERED THAT A FAULTY SOLENOID HAD CAUSED THE MALFUNCTION. THE SOLENOID WAS REPLACED AND THE UNIT RETURNED TO SERVICE. THE PATIENT WAS NOT HARMED BY THE PROBLEM, BUT THERE WAS A DELAY OF APPROXIMATELY 38 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TABLE, SURGICAL FQO SKYTRON, DIVISION OF KMW GROUP 3500B *

    Patients

    Seq Age Sex Outcome Treatment
    1 *