BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINOS DRF MAX

    MDR report key: 16503632 · Received March 8, 2023

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    3004977335-2023-00013
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 23, 2023
    Report Date
    April 22, 2023
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K173639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10 MANUFACTURER NARRATIVE: SIEMENS HEALTHCARE INVESTIGATED THE REPORTED ISSUE IN DETAIL. IT WAS STATED THAT IN THE SAME ROOM AS THE LUMINOS DRF MAX SYSTEM THERE IS AN ORTHOPANTOGRAM OP100 BY A DIFFERENT MANUFACTURER. AS A RESULT, THERE IS HARDLY ANY SPACE TO WALK THROUGH THE ROOM. ACCORDING TO THE INFORMATION RECEIVED, THE ORTHOPANTOGRAM OP100 WAS INSTALLED IN THE ROOM AFTER THE LUMINOS DRF MAX SYSTEM. BASED ON THE INFORMATION RECEIVED FROM THE SERVICE ORGANIZATION, IT CAN BE CONCLUDED THAT THERE IS NO TECHNICAL PROBLEM WITH THE LUMINOS DRF MAX SYSTEM. THE PROVIDED IMAGES SHOW THAT THE ORTHOPANTOGRAM OP100 IS LOCATED AT THE HEAD END OF THE LUMINOS DRF MAX. ACCORDING TO THE RECEIVED ROOM PLAN, THE LUMINOS DRF MAX COULD BE OPERATED WITHIN THE NORMAL PARAMETERS WITHOUT THE ADDITIONAL SYSTEM. THE PROVIDED IMAGES SHOW THAT THERE IS ONLY 7CM SPACE BETWEEN THE EXTRACTED TABLETOP AND THE OTHER SYSTEM. IT IS DESCRIBED IN THE STARTUP INSTRUCTIONS THAT A GENERAL SAFETY DISTANCE OF 50CM FROM THE TABLETOP MUST BE MAINTAINED (SEE XPD3-520.815.03.10.02/11.22 CHAPTER 4.3 ¿ ROOM DIMENSIONS). WHEN THE TABLETOP IS FULLY EXTENDED TOWARD THE HEAD, THE REQUIRED SAFETY DISTANCE IS NOT MAINTAINED IN CERTAIN POSITIONS OF THE SYSTEM. THEREFORE, THE MOVEMENT RANGE OF THE TABLETOP IN THE HEAD AREA MUST BE LIMITED. IT IS ALSO DESCRIBED IN THE STARTUP INSTRUCTIONS HOW TO PROGRAM THE CURRENT ROOM DIMENSIONS, LIMITATIONS, AND ADDITIONAL OBSTACLES (SEE XPD3-520.815.03.10.02/11.22 CHAPTER 4.3.1 ¿ ENTERING THE ROOM DIMENSIONS, CHAPTER 4.6 ¿ HANDLING OBSTACLES). THE CUSTOMER WAS ADVISED NOT TO USE THE SYSTEM IN THE CURRENT SITUATION. IF THE CUSTOMER REFUSES TO ACCEPT A RESTRICTION ON SYSTEM MOVEMENTS, WRITTEN CONFIRMATION IS REQUIRED THAT THE CUSTOMER IS AWARE OF THE RISK AND ACCEPTS RESPONSIBILITY. THE COMPLAINT WAS CLOSED WITH THIS STATEMENT.

    Additional Manufacturer Narrative · 0

    A CUSTOMER FACILITY CONTACT NAME WAS NOT PROVIDED TO SIEMENS. THE COMPLAINT WAS INITIATED BY SIEMENS. THE CUSTOMER FACILITY PHONE NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITION INFORMATION BECOMES AVAILABLE UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    G4: 510(K) NUMBER WAS OMITTED IN ERROR IN THE INITIAL REPORT SUBMITTED TO THE FDA ON 03/08/2023 AND PROVIDED IN THIS SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER INSTALLED TWO SYSTEMS IN A VERY SMALL ROOM. THE INSTALLED SYSTEMS INCLUDE A SIEMENS HEALTHINEERS LUMINOS DRF MAX AND A SYSTEM FOR ORTHOPANTOGRAMS BY A DIFFERENT MANUFACTURER. A SIEMENS HEALTHINEERS SERVICE ENGINEER OBSERVED THAT THERE IS HARDLY ANY SPACE TO WALK THROUGH THE ROOM. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE INSTALLATION AND THE FOREIGN MANUFACTURER¿S SYSTEM. SIEMENS HEALTHINEERS HAS NOT BEEN MADE AWARE OF ANY ADVERSE EVENTS ASSOCIATED WITH THIS ROOM SITUATION. HOWEVER, IN WORST CASE SCENARIO DUE TO THE ROOM CONFIGURATION, CRUSHING OF A PATIENT OR OPERATORS BY A SYSTEM MAY OCCUR AND RESULT IN A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125148 LUMINOS DRF MAX INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10762471

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown