BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITALDIAGNOST DUAL DETECTOR

    MDR report key: 21823701 · Received April 11, 2025

    Report

    Report Number
    3003768251-2025-000055
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 24, 2025
    Report Date
    April 11, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    MQB
    PMA / PMN Number
    K090625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE ID: (B)(4). DIGITALDIAGNOST R2.X IS AN X-RAY UNIT FOR NEARBY CONTROLLED DIGITAL AND CONVENTIONAL FLUOROSCOPY AND RADIOGRAPHY. FOR ANATOMIES THAT ARE LARGER THAN THE DETECTOR SIZE, IT IS POSSIBLE TO MAKE A SERIES OF EXPOSURES COVERING THE WHOLE ANATOMY (FOR EXAMPLE FULL SPINE OR FULL LEGS). THESE INDIVIDUAL IMAGES CAN BE "STITCHED" TOGETHER VIA THE SOFTWARE PROGRAM. FOR PROPER PATIENT POSITIONING AND SUPPORT, THE PATIENT CAN BE PLACED ON THE SO-CALLED STITCHING PATIENT SUPPORT OR STITCHING STAND (9890 010 87432), A PLATFORM WITH TWO HANDLES THAT THE PATIENT CAN HOLD ON TO DURING THE EXAMINATION. FOR THE EASE OF USE DURING TRANSPORTATION, THE PATIENT SUPPORT FOR STITCHING HAS WHEELS AND A FOLDING FOOTBOARD. THE FOOTBOARD IS CONNECTED TO THE FRAME VIA TWO HINGES AND A BRAKE CYLINDER. IT HAS TO BE FOLDED UP AND FIXED BY A HOOK FOR TRANSPORTATION, E.G. FROM ONE ROOM TO ANOTHER. THE BRAKE CYLINDER WAS INTRODUCED WITH FCO71200185 AND HAS THE TASK TO ENSURE THAT THE FOOTBOARD LOWERS ITSELF SLOWLY (WITHIN 5-7 SECONDS) WHEN THE HOOK IS RELEASED, TO PREVENT THE FOOTPLATE FROM FALLING ON THE FOOT OF A PERSON. IF THE OPERATOR STEPS ON THE FOOTBOARD WHILE IT IS STILL MOVING DOWN, THE MOUNTING OF THE BRAKE CYLINDER CAN BREAK, AND THE FOOTBOARD FALLS DOWN IMMEDIATELY. IN A WORST CASE, IT MAY HIT THE FOOT OF A PERSON AND BREAK A BONE. PHILIPS RECEIVED A COMPLAINT ON DIGITALDIAGNOST R2.X INDICATING THE PATIENT SUPPORT PROBLEM. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM. THE FIELD SERVICE ENGINEER (FSE) PERFORMED ANALYSIS AND CONCLUDED THAT THE HINGE OF HYDRAULIC SPRING ON PATIENT SUPPORT IS DETACHED. THE HINGE WAS REATTACHED AND TIGHTENED THE JOINT. VERIFIED THE FOOTSTEP WITH THE SPRING AND FOOTBOARD TESTED OKAY. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS WEAR AND TEAR. THE REPORTED PROBLEM WAS CONFIRMED BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SUPPORT PROBLEM. THE DEVICE WAS IN CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM. ADDITIONAL INFORMATION RECEIVED THAT THE HINGE OF HYDRAULIC SPRING ON PATIENT SUPPORT IS DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2425731 DIGITALDIAGNOST DUAL DETECTOR SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) MQB PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST DUAL DETECTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown