BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYDIAGNOST ELEVA DRF

    MDR report key: 22409920 · Received July 7, 2025

    Report

    Report Number
    3003768251-2025-000089
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    June 10, 2025
    Report Date
    November 7, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    JAA
    UDI-DI
    00884838074255
    PMA / PMN Number
    K031535
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE ID: (B)(4). EASYDIAGNOST ELEVA R5.X IS A DIGITAL RADIOGRAPHY AND FLUOROSCOPY SYSTEM THAT OFFERS FAST IMAGING, FLEXIBLE CONFIGURATIONS, AND HIGH-QUALITY RESULTS WITH AN INTUITIVE USER INTERFACE. THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS FIELD SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON EASYDIAGNOST ELEVA R5.X INDICATING THAT FIELD SERVICE ENGINEER INJURY AT CUSTOMER SITE, ON EASY DIAGNOSTIC ELEVA. WHILE THE FSE WAS REPLACING THE COMPRESSION BRAKE, HIS FINGER GOT PINCHED. FSE HAD TO GO TO THE EMERGENCY ROOM AND NEEDED STITCHES. THE FIRE DEPARTMENT HAD TO DESTROY THE SPIDER MECHANISM TO FREE HIS FINGER. THE CFMS FORM STATES THAT THE CLEVELAND TRAINING DID NOT COVER SPIDER REMOVAL, AND THE SECTION ON REPLACING THE COMPRESSION BRAKE DOES NOT INCLUDE SPIDER REMOVAL STEPS UNLIKE OTHER MANUALS THAT DO PROVIDE THIS INFORMATION. THE DEVICE WAS OUTSIDE OF CLINICAL USE. THE FIELD SERVICE ENGINEER (FSE) PERFORMED AN ANALYSIS AND CONCLUDED THAT THE SCOPO MOTOR WAS READING ONLY 3.4 OHMS, WHEREAS IT SHOULD BE BETWEEN 15 AND 20 OHMS. THE SPIDER WAS REMOVED, THE MOTOR WAS REPLACED, AND THE SPIDER WAS REINSTALLED. THE STAND GEOMETRIES CONTROLLER WAS ALSO REPLACED, AND NECESSARY CALIBRATIONS, TESTING, AND VERIFICATION WERE CARRIED OUT. HOWEVER, EVEN AFTER REPLACING MULTIPLE PARTS, THE ISSUE PERSISTED. FURTHER INVESTIGATION REVEALED THAT THE CABLE CONNECTING THE GEOMETRY CIRCUIT BOARD COMPARTMENT TO THE TABLE¿S LONGITUDINAL MOTOR WAS DAMAGED LIKELY DUE TO REPEATED MOVEMENT OF THE SCOPOMAT OVER TIME. THE DAMAGED CABLE LOCATED UNDER THE TABLE WAS REPLACED, AND THE SYSTEM WAS VERIFIED TO BE FULLY FUNCTIONAL. THE STAFF CONFIRMED THAT THE TABLE IS OPERATING CORRECTLY AND SUCCESSFULLY PERFORMED A TEST PATIENT FLUOROSCOPY, WHICH WAS SENT TO PACS WITHOUT ISSUES. AN INVESTIGATION RECORD COMPLETED BY THE NORTH AMERICA (NA) HEALTH AND SAFETY TEAM SUMMARIZES THE INCIDENT AS FOLLOWS: THE FIELD SERVICE ENGINEER SUPERVISOR AND THE 2 TRAINEES WERE WORKING ON REPLACING THE COMPRESSION MOTOR ON SCOPOMAT FROM AN EASY DIAGNOST ELEVA R5.X SYSTEM. THE TRAINEE ENGINEER WAS REMOVING THE SPIDER GEAR IN ORDER TO ACCESS THE COMPRESSION MOTOR. THE SPIDER GEAR WAS STILL HAVING THE SPRING TENSION WHICH CAUSED THE GEAR TO ROTATE TRAPPING THE TRAINEE ENGINEER'S FINGER BETWEEN THE TEETH. THE EMPLOYEE'S FINGERS WERE HOLDING THE FRAME FROM INSIDE THE OUTER PERIMETER RAILING, WHICH IS WHERE THE SPRING COMPRESSION RELEASED AND PINCHED THE FINGER BETWEEN THE ROLLERS. FURTHER INVESTIGATION BY RESEARCH AND DEVELOPMENT (R&D) TEAM REVEALED THAT THIS INCIDENT HAPPENED BECAUSE THE STORED ENERGY IN THE SPIDER BANDS WAS NOT RELEASED, AS THE SAFETY BOLTS REMAINED ENGAGED. THIS OCCURRED DUE TO INATTENTIVE EXECUTION OF THE MAINTENANCE PROCEDURE AND INADEQUATE ADHERENCE TO THE SERVICE MANUAL. THE SERVICE MANUAL PROVIDES INSTRUCTIONS FOR REPLACING THE SPIDER GEAR AND INCLUDES CAUTIONARY GUIDANCE TO PREVENT OPERATOR NEGLIGENCE. SERVICE MANUAL INCLUDES WARNING NOT TO RELEASE THE SPIDER WITH A RATCHET. THE SPRING TENSION RELEASES ABRUPTLY. THE INCIDENT RESULTED FROM NOT FOLLOWING ESTABLISHED SAFETY PROCEDURES, RATHER THAN FROM ANY SYSTEM MALFUNCTION OR DESIGN FLAW. THE ROOT CAUSE OF THIS ACCIDENT HAS HENCE BEEN EVALUATED AS THE ERROR BY THE SERVICE PERSONNEL (NEGLIGENCE, INATTENTIVENESS). THE SPIDER GEAR WAS UNDER SPRING TENSION, WHICH WAS NOT PROPERLY MANAGED DURING DISASSEMBLY. THIS ISSUE IS LIMITED TO MAINTENANCE ACTIVITIES, WHERE AN ESTABLISHED PROCESS EXISTS BUT WAS NOT FOLLOWED. THERE ARE NO CLINICAL USE IMPACT AND NO SYSTEM MALFUNCTION DESCRIBED. A FORMAL SAFETY ALERT WAS ISSUED VIA EMAIL TO ALL RELEVANT SERVICE PERSONNEL, UNDERSCORING THE CRITICAL IMPORTANCE OF ADHERING TO THE SERVICE MANUAL PROCEDURES FOR RELEASING THE SPIDER GEAR¿S STORED ENERGY PRIOR TO DISASSEMBLY. THE COMMUNICATION REFERENCED SERVICE MANUAL AND EMPHASIZED THE REVIEW OF WARNING LABELS AND INSTRUCTIONS. THIS ACTION WAS TAKEN TO REINFORCE SAFE WORK PRACTICES AND MITIGATE THE RISK OF SIMILAR INJURIES IN THE FUTURE. THIS ISSUE IS LIMITED TO MAINTENANCE ACTIVITIES, WHERE AN ESTABLISHED PROCESS EXISTS BUT WAS NOT FOLLOWED. THERE ARE NO CLINICAL USE IMPACT AND NO SYSTEM MALFUNCTION DESCRIBED.

    Additional Manufacturer Narrative · 0

    REFERENCE ID: (B)(4). EASYDIAGNOST ELEVA R5.X IS A DIGITAL RADIOGRAPHY AND FLUOROSCOPY SYSTEM THAT OFFERS FAST IMAGING, FLEXIBLE CONFIGURATIONS, AND HIGH-QUALITY RESULTS WITH AN INTUITIVE USER INTERFACE. PHILIPS RECEIVED A COMPLAINT ON EASYDIAGNOST ELEVA R5.X INDICATING THAT FIELD SERVICE ENGINEER (FSE) INJURED AT CUSTOMER SITE, ON EASY DIAGNOSTIC ELEVA SYSTEM SERVICE. THE DEVICE WAS OUTSIDE OF CLINICAL USE. WHILE THE FSE WAS REPLACING THE COMPRESSION BRAKE, HIS FINGER GOT PINCHED. FSE HAD TO GO TO THE EMERGENCY ROOM AND NEEDED STITCHES. THE FIRE DEPARTMENT HAD TO DESTROY THE SPIDER MECHANISM TO FREE HIS FINGER. FSE SUSTAINED A CUT AND FRACTURE TO THE RIGHT-HAND FINGER DURING WORK. INITIAL TREATMENT INCLUDED SUTURES AND PRESCRIPTION MEDICATION. THE CONDITION WILL BE MONITORED FURTHER TO DETERMINE IF SURGICAL INTERVENTION IS REQUIRED. INVESTIGATION STILL GOING-ON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FIELD SERVICE ENGINEER (FSE) INJURED AT CUSTOMER SITE, ON EASY DIAGNOSTIC ELEVA SYSTEM SERVICE. THE DEVICE WAS OUTSIDE OF CLINICAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898638 EASYDIAGNOST ELEVA DRF SYSTEM, X-RAY, STATIONARY JAA PHILIPS MEDICAL SYSTEMS DMC GMBH EASYDIAGNOST ELEVA DRF 00884838074255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention