MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG AXIOM LUMINOS DRF; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10094200

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 12/26/2023

Event Type  malfunction  

Manufacturer Narrative

E1: the reporting facility contact phone number is (b)(6).H3, h6: initial corrective actions/preventive actions implemented by the manufacturer: the joystick was replaced at the affected site.The customer was instructed to not place the monitor cart in the movement range of the system during examinations and to press the emergency stop button to stop any unintended movement in the future.No general problem has been detected for the installed base which requires an immediate action.Manufacturers preliminary analysis: with the currently available information it is assumed that the issue might have been caused by a malfunctioning joystick.The investigation is ongoing.Siemens healthineers will submit a supplemental report if additional information is obtained upon completion of the investigation.

Event Description

On (b)(6) 2024, siemens healthineers received a letter from the customer describing an incident with a patient that happened on (b)(6) 2023, during an examination using the axiom luminos drf system.According to the letter, there was a miscommunication between the joystick and the table during the first controlled table movement using the joystick.As a result, the tabletop spontaneously shifted towards the head end at normal speed without any manual intervention, causing the patient to hit the head against a hard object (presumably the metal handle of the monitor cart).It was communicated by the customer that the patient hurt the head and reported a strange feeling in their fingers.The patient was brought to the emergency department for further evaluation.No adverse medical consequences to the patient were found.

• Brand Name: AXIOM LUMINOS DRF
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 18605095
• MDR Text Key: 334066232
• Report Number: 3004977335-2024-00010
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K062623
• 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
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094200
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 40 YR