BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWISSRAY DDRFORMULA B

    MDR report key: 6373663 · Received March 2, 2017

    Report

    Report Number
    9614430-2017-00002
    Event Type
    Malfunction
    Date Received
    March 2, 2017
    Date of Event
    August 23, 2016
    Report Date
    March 2, 2017
    Manufacturer
    SWISSRAY INTERNATIONAL, INC.
    Product Code
    KPR
    PMA / PMN Number
    K052943
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SWISSRAY INTERNATIONAL, INC. (SRI) FIELD SERVICE ENGINEER (FSE) COULD NOT REPRODUCE THE ISSUE. THERE WAS NO UNINTERRUPTABLE POWER SUPPLY (UPS) ON THIS SYSTEM AND THERE WERE SUBSTANTIAL POWER ISSUES IN THE AREA OF THE HOSPITAL DUE TO SIGNIFICANT FLOODING. THE FSE INSTALLED A NEW UPS TO THE SYSTEM TO ENSURE THE POWER WAS CLEAN WHEN MULTIPLE MOTORS MOVE ON THE SYSTEM. THE FSE RETRIEVED THE SYSTEM LOGS AND FORWARDED THEM TO INSTALLED BASE MANAGER. THE INSTALLED BASE MANAGER EXAMINED THE LOGS FROM THE SYSTEM. THE LOGS SHOWED THE SEQUENCE OF EVENTS. THE LOGS SHOWED THAT THERE WAS A BUCKY COLLISION. THEN THERE WAS UNWANTED MOVEMENT OF THE BUCKY. THE DDRFORMULA HAS A PLC SOFTWARE SAFETY SYSTEM WHICH IS DESIGNED TO PREVENT THE SYSTEM FROM MOVING ON ITS OWN. THE PLC SOFTWARE WATCHES THE ENCODER TO SEE IF THE ENCODER IS RUNNING, AND WILL ACTIVATE BRAKES IF IT DETECTS UNINSTRUCTED MOVEMENT. A SIMILAR ISSUE HAD OCCURRED AGAIN WITH THIS SYSTEM ON (B)(6) 2016, DOCUMENTED BY SRI. THE PATIENT WAS IN THE ROOM BUT WAS SAFELY KEPT OUTSIDE RANGE OF THE SYSTEM'S MOTION WHILE THE TECHNICIAN WAS POSITIONING THE SYSTEM. THERE WAS NO PATIENT INJURY OR DEATH. THE FSE COULD NOT REPRODUCE THE ISSUE. THE FSE UPDATED THE PLC SOFTWARE. UNDER COMPLAINT (B)(4), THE FSE FOUND THAT THE CONTROLLED AREA NETWORK (CAN) TERMINATION SETTINGS WERE INCORRECT DUE TO AN INCORRECT JUMPER CONFIGURATION. ON EVERY MOTOR, THERE IS AN INTERFACE CARD WHICH HAS A JUMPER, AND THE FSE FOUND THAT WHERE THE BUS SHOULD HAVE BEEN TERMINATED WITH THE C-ARM MOTOR WAS NOT TERMINATED PROPERLY. THE JUMPER CONFIGURATION HAD BEEN SET WRONG FROM THE FACTORY. BASED ON THE INCIDENT, SRI INITIATED A COMPREHENSIVE INVESTIGATION OF THIS AND SIMILAR COMPLAINTS. AS A RESULT OF THE INVESTIGATION, SRI INITIATED MANDATORY FIELD CHANGE ORDER (MFCO) # (B)(4). THE MFCO COVERED THE SYSTEM IN THIS COMPLAINT. FROM AN ANALYSIS OF COMPLAINTS RELATED TO THE MFCO: POSSIBLE CAUSES OF UNINTENDED MOVEMENT WERE INCORRECT CONTROLLED AREA NETWORK (CAN) TERMINATION SETTINGS OR A POSSIBLE DRIFT OF THE CALIBRATED HOME POSITION CAUSED BY PREMATURE STOPPING OF THE MOTORS DUE TO INCORRECT TIME DELAY RELAY (TDR) SETTINGS. THIS MFCO IS A SAFETY ALERT, NOT A RECALL, BECAUSE THE DEVICE WOULD POSE A RISK OF SUBSTANTIAL HARM ONLY IN CERTAIN CIRCUMSTANCES. ALTHOUGH THIS IS A MANDATORY FCO, MEANING THAT EACH X-RAY SYSTEM MUST BE INSPECTED/ REPAIRED/CONFIRMED AS PART OF A FIELD CORRECTION, SECTION 1.5 "MECHANICAL SAFETY" OF THE DDRFORMULA B USER MANUAL (DOCUMENT (B)(4)) INSTRUCTS THAT BEFORE ANY AUTOMATIC POSITIONING, TO ENSURE THAT NO PERSON OR OBJECT IS IN THE MOVEMENT RANGE OF THE DEVICE. IN ADDITION, THE DDRFORMULA B HAS A SECONDARY SAFETY COLLISION DETECTION SYSTEM IN WHICH COLLISION SENSORS WILL DETECT A COLLISION OF THE C-ARM AND STOP MOVEMENT OF THE SYSTEM. IN ADDITION, THERE HAVE NOT BEEN ANY SIMILAR PAST MALFUNCTIONS OF THIS PRODUCT MODEL (DDRFORMULA B) WHICH CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    THE CUSTOMER X-RAY TECHNICIAN HAD FIRST IMAGED THE PATIENT AT THE AP KNEE POSITION WHERE THE TUB DETECTOR ANGLE (TDA) WAS APPROXIMATELY 0 DEGREES, WHERE THE BUCKY WAS STATIONARY, WITH SEVERAL INCHES OF SPACE BETWEEN THE BUCKY AND THE PATIENT'S FEET. THE TECHNICIAN THEN USED THE REMOTE TO MANUALLY MOVE THE SYSTEM TO THE PA FLEXION POSITION, BY ROTATING THE C-ARM TO ACHIEVE A HIGHER TDA ANGLE OF 15 DEGREES, SO THAT THE COLLIMATOR WOULD BE HIGHER IN THE AIR WHILE THE BUCKY WOULD REMAIN STATIONARY. THE TECHNICIAN NOTICED THAT THE BUCKY HAD STARTED TO LOWER BY ITSELF, SO THE TECHNICIAN RELEASED THE REMOTE BUTTON BUT THE BUCKY CONTINUED TO MOVE DOWN. AS THE BUCKY MOVED DOWN TOWARDS THE FLOOR, THE BUCKY TRAPPED BOTH OF THE PATIENT'S FEET UNDERNEATH. WHEN THE BUCKY TRAPPED THE PATIENT'S FEET, THE SYSTEM'S SECONDARY SAFETY COLLISION SENSORS DETECTED THE COLLISION AND STOPPED THE MOVEMENT OF THE BUCKY. THE PATIENT WAS STUCK BUT UNHARMED. THE PATIENT WAS WEARING STEEL TOE SHOES. THE HOSPITAL STAFF THEN PULLED THE PATIENT'S FEET OUT FROM UNDERNEATH THE BUCKY. THERE WAS NO PATIENT INJURY OR DEATH. AFTERWARDS, THE SYSTEM WOULD NOT MOVE AND HAD BLINKING RED LED LIGHTS ON THE BUCKY. THE TECHNICIAN THEN HIT THE ESCAPE SWITCH ON THE SYSTEM. THE TECHNICIAN THEN PRESSED THE REMOTE UP BUTTON AND THE C-ARM MOVED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155149 SWISSRAY DDRFORMULA B DDRFORMULA KPR SWISSRAY INTERNATIONAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR