BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMAGIQ

    MDR report key: 5056408 · Received September 4, 2015

    Report

    Report Number
    5056408
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    June 12, 2015
    Report Date
    August 14, 2015
    Manufacturer
    STILLE SURGICAL INC.
    Product Code
    GDC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT ARRIVED TO OPERATING ROOM. BOTH PATIENT BED AND OPERATING ROOM TABLE LOCKED AND DOUBLE CHECKED BY STAFF, ANESTHESIA AND ATTENDING SURGEON. AFTER PROCEDURE STARTED, SURGEON ASKED ANESTHESIA TO ADJUST HEIGHT ON BED, AND COMPLETED, HOWEVER, OPERATING ROOM BED MALFUNCTIONED AND UNLOCKED. ATTEMPTED TO LOCK BED BY ANESTHESIA, OPERATING ROOM STAFF, BED UNABLE TO LOCK. CHARGE NURSE NOTIFIED AND ATTEMPTED TO LOCK BED, BED CHECKED: PLUGGED IN, TURNED OFF AND RESET WITH NO RESULTS TO LOCKS IN PLACE. CASE FINISHED AND PATIENT MOVED VERY CAREFULLY TO OWN BED WITH SEVERAL STAFF MEMBERS ASSISTING ON MOVING PATIENT. CLINICAL ENGINEERING CHECKED BED AND FOUND THAT THE DEVICE HAD DEAD BATTERIES DUE TO A FAILED POWER CONNECTOR AT THE BASE OF THE TABLE. THE CONNECTOR WAS REPAIRED, THE BATTERIES CHARGED, AND FUNCTION TESTED. DEVICE OPERATES PER OME SPECS. DEVICE RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588958 IMAGIQ TABLE, OPERATING GDC STILLE SURGICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR