MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH LUMINOS DRF MAX; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 10762471

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2022

Event Type  malfunction  

Manufacturer Narrative

Initial corrective actions-preventive by manufacturer: the siemens customer service engineer (cse) evaluated the system by executing a range of movements, but no errors appeared.The cse also checked the brakes in the d20 board and did not find any errors.The dead man grip functionality was also checked, and it was working as specified.The cse put a weight on the head-end position and there were no sudden tilt movements.It was communicated to the user that the system has been taken out of use until the issue is investigated.Manufacturer's preliminary analysis: the cause for the issue has not yet been determined.The investigation is ongoing.A supplemental report will be submitted if additional information is received upon completion of the investigation.

Event Description

It was stated by the user that during a patient examination using the luminos drf max system, the patient table started tilting in the counterclockwise direction causing the patient to fall onto the floor.The patient was not injured.A service engineer checked the system after the event and could not find any system malfunction.Although there was no patient injury associated with this event, in a worst-case scenario, a serious patient injury may result if this issue recurs.The user always has the option to stop unintended system movement by pressing the emergency stop button.

Manufacturer Narrative

The described issue was investigated in detail.As previously reported it was stated that the table suddenly started to tilt counterclockwise.As a result, the patient fell off the examination table.According to the information received, the patient was not injured.The provided image shows the system in a horizontal position.The compression tube is not mounted.However, this is not related to the described problem.No anomalies could be detected.The log files provided have been analyzed by the product experts.The analysis did not reveal any hardware or software related issues.According to the service engineer, the flight recorder was inactive at the time of the incident.Therefore, no log files were recorded.However, flight recorder logs were provided, but since they contain data from 2019 and 2020, they do not cover the time of the incident and were therefore not considered for the investigation.The analysis of the provided flc log files showed that at the communicated time, the joystick for table tilt ccw was operated on the rcm1.The system then moved upwards from 73cm to 113cm.After reaching the tilt height, the system tilted to -5.2 degrees.During this process, the joystick for table tilt ccw was still active.Finally, the table was moved directly back to 0 degrees and lowered to about 87cm.According to the log files, all movements were triggered by the rcm1.No system failure or defective hardware (buttons, joysticks or other hardware) could be detected.According to the information from the service organization, also no system malfunction was detected on site.No errors were found.The system worked as intended.Therefore, it is assumed that the operator initiated the system movement by accident.In case of unintentional movement, the operator can stop any movement by moving in the opposite direction or by pressing the emergency stop buttons to prevent harm to the patient or themselves.The location of the emergency stop buttons is described in the operator manual (xpd3-520.620.01.01.02 chapter ¿general safety¿ on pages 33-35 / 80).Since no system malfunction could be determined the complaint is closed without further measures.

• Brand Name: LUMINOS DRF MAX
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1 or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstr. 1 or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 16088029
• MDR Text Key: 308360360
• Report Number: 3004977335-2023-00005
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K173639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10762471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/30/2022
• Initial Date FDA Received: 01/03/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Male