BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KVUE¿

    MDR report key: 18659007 · Received February 7, 2024

    Report

    Report Number
    18659007
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    December 1, 2023
    Report Date
    December 7, 2023
    Manufacturer
    QFIX
    Product Code
    JAI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT CAME DOWN FROM INPATIENT TO RADIATION CLINIC FOR RADIATION TREATMENT. PATIENT WAS TRANSFERRED TO TREATMENT TABLE VIA SLIDE BOARD BY TWO RADIATION THERAPISTS AND ONE REGISTERED NURSE (RN). WHILE PATIENT WAS BEING PLACED IN POSITION ON TABLE, HE VERBALIZED THE NEED TO VOMIT. RN TURNED TO GRAB EMESIS BAG FROM DRAWER. WHILE TURNED, RN HEARD THE RADIATION THERAPIST SAY, "GUYS I NEED SOME HELP." RN QUICKLY TURNED AROUND TO FIND THE PATIENT AND HALF OF THE TREATMENT TABLE ON THE FLOOR. RADIATION THERAPIST WITNESSED THE PATIENT TURNING TO THE RIGHT ON TREATMENT TABLE WHICH THEN UNLATCHED HALF OF THE TREATMENT TABLE CAUSING IT TO SLIDE OFF. RADIATION THERAPIST ATTEMPTED TO CATCH THE PATIENT BEFORE HITTING HIS HEAD ON THE FLOOR BUT WAS UNSUCCESSFUL. TWO RNS AND TWO RADIATION THERAPISTS THEN HELPED THE PATIENT UP OFF THE FLOOR. UPON ASSESSMENT, PATIENT VERBALIZED PAIN ON THE LEFT SIDE OF HIS HEAD BUT WAS UNABLE TO GIVE A NUMERICAL NUMBER FOR HIS PAIN. ON-SITE PROVIDER WAS NOTIFIED OF THE EVENT AS WELL AS INPATIENT RN AND HOSPITALIST. HOUSE SUPERVISOR ARRIVED AT THE SCENE OF THE EVENT. RAPID RESPONSE WAS CALLED. PATIENT WAS THEN TRANSFERRED TO IMAGING FOR STAT CT HEAD SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792947 KVUE¿ COUCH, RADIATION THERAPY, POWERED JAI QFIX RT-4551KVCL-V

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other