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

Model Number 10094200

Device Problem Unintended Movement (3026)

Patient Problem Bruise/Contusion (1754)

Event Date 03/08/2022

Event Type  Injury  

Manufacturer Narrative

Emergency stop button is available to the user to stop all system movements.A supplemental report will be submitted if additional information becomes available.Internal id #: (b)(4).

Event Description

It was reported that the user wanted to tilt the patient table of the axiom luminos drf unit from the upright position into a horizontal position (0 degrees).According to the user, the table did not stop at 0 degrees and continued to tilt downwards.This caused the patient to slide off the table and hit her head on the floor.It was communicated that the patient seemingly suffered a bruise.The reported incident occurred in (b)(6).

Manufacturer Narrative

The reported issue was investigated in detail.According to the information received from the service technician the affected system is working properly.It was confirmed by the staff of the clinic's x-ray department that this issue was caused by an operator error due to not enough experience and not enough attention during procedure.Furthermore, it was confirmed by longstanding operators that the system never moved by itself.Considering this incident which could also have led to a serious and/or lasting injury of the patient a usability training (application training) of the operator is strongly recommended.No system malfunction could be determined, the system works as specified.The complaint is therefore closed with this statement and without further measures.Internal id# (b)(4).

• Brand Name: AXIOM LUMINOS DRF
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19335 ; 4843234198
• MDR Report Key: 14161150
• MDR Text Key: 289669318
• Report Number: 3004977335-2022-24314
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K062623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10094200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female