BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAD

    MDR report key: 7233412 · Received February 1, 2018

    Report

    Report Number
    9616014-2018-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2018
    Date of Event
    January 11, 2018
    Report Date
    April 9, 2018
    Manufacturer
    ARCOMA AB
    Product Code
    KPR
    PMA / PMN Number
    K113855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBLEM COULD NOT BE RECREATED. THE CONTROL BOARD HAS BEEN ANALYSED BY ORIGINAL MANUFACTURER, SYFM CO., LTD (SHIN YOUNG FOR M). NO FAILURE DETECTED, THE CONTROL BOARD WORKS AS INTENDED WITHIN SPECIFICATIONS. USER ERROR CAN NOT BE RULED OUT. THE DEVICE IS CONSIDER SAFE, THE USER MANUAL CLEARLY STATES ON THE FIRST PAGE THE IMPORTANCE OF TRAINED PERSONNEL, HOW TO OPERATE THE DEVICE AND THAT THE EMERGENCY STOP SHOULD BE USED.

    Description of Event or Problem · 0

    UNCONTROLLED MOVEMENT OF THE U-ARM. A BILATERAL KNEE EXAMINATION (RIGHT KNEE) HAS BEEN PERFORMED ON A LYING PATIENT WITH NEAR VERTICAL BEAM DIRECTION (5 °), THE DETECTOR UNDERNEATH THE TABLE. THE U-ARM HAS THEN BEEN LOWERED AND POSITIONED FOR A SUNRISE OR SKYLINE EXAMINATION WHERE THE TUBE IS TILTED ABOUT 20 ° TO GET A PICTURE OF THE KNEE BOWL. THE USER HAS RELEASED THE BUTTON AT THE DESIRED POSITION, BUT THE U-ARM CONTINUED TO ROTATE UNTIL IT STOPPED IN POSITION FOR A HORIZONTAL BEAM TARGETING. THE TABLE WITH THE PATIENT WAS PULLED UPWARDS AND THE USERS WHO WAS FOCUSED ON THE PATIENT DID NOT ACTIVATE THE EMERGENCY STOP. NO ONE WAS INJURED.

    Additional Manufacturer Narrative · 1

    RCA STILL UNDER INVESTIGATION. THE PROBLEM COULD NOT BE RECREATED. CONTROLBOARD IS EXCHANGED. THE OLD BOARD IS SENT TO US FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    UNCONTROLLED MOVEMENT OF THE U-ARM. A BILATERAL KNEE EXAMINATION (RIGHT KNEE) HAS BEEN PERFORMED ON A LYING PATIENT WITH NEAR VERTICAL BEAM DIRECTION (5 °), THE DETECTOR UNDERNEATH THE TABLE. THE U-ARM HAS THEN BEEN LOWERED AND POSITIONED FOR A SUNRISE OR SKYLINE EXAMINATION WHERE THE TUBE IS TILTED ABOUT 20 ° TO GET A PICTURE OF THE KNEE BOWL. THE USER HAS RELEASED THE BUTTON AT THE DESIRED POSITION, BUT THE U-ARM CONTINUED TO ROTATE UNTIL IT STOPPED IN POSITION FOR A HORIZONTAL BEAM TARGETING. THE TABLE WITH THE PATIENT WAS PULLED UPWARDS AND THE USERS WHO WAS FOCUSED ON THE PATIENT DID NOT ACTIVATE THE EMERGENCY STOP. NO ONE WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77854 PANORAD PANORAD X-RAY SYSTEM KPR ARCOMA AB

    Patients

    Seq Age Sex Outcome Treatment
    1