BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 656446 · Received December 2, 2005

    Report

    Report Number
    656446
    Event Type
    Malfunction
    Date Received
    December 2, 2005
    Date of Event
    August 17, 2005
    Report Date
    December 2, 2005
    Manufacturer
    SKYTRON, DIVISION OF KMW GROUP
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    MD PERFORMING A BLADDER BIOPSY CASE. THE URO-SLIDING BED WOULD NOT SLIDE AT ALL CAUSING THE C-ARM NOT TO FOCUS TO THE KIDNEY FOR THE RETROGRADE PART OF THE CASE. MANUFACTURER WAS NOTIFED. TAPE WAS FOUND UNDER THE TABLE NEAR WHERE THE TABLE SLIDING DEVICE IS. TAPE REMOVED AND WAS FUNCTIONING. HOSPITAL CLINICAL ENGINEERING WAS NOTIFIED. WHEN CLINICAL ENGINEERING EVALUATED THE TABLE, THEY WERE ABLE TO MAKE THE TABLE MOVE; HOWEVER, NOT TO FULL EXTENSION. TABLE TO CLINICAL ENGINEERING FOR TESTING. IN CLINICAL ENGINEERING THE TABLE OPERATED PROPERLY WITH OR WITHOUT WEIGHT ON THE TABLE AND ALSO WITH THREE TECHS SITTING ON THE TABLE. WHEN SKYTRON EVALUATED THE TABLE, IT WORKED FINE FOR THEM AS WELL. SKYTRON HAD PLANNED TO BRING A MORE EXPERIENCED REP TO CHECK THE DEVICE ONCE AGAIN PER THE DIRECTOR OF CLINICAL ENGINEERING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *