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

Model Number 10762472

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 01/14/2022

Event Type  malfunction  

Manufacturer Narrative

Siemens local service inspected the device and the footrest and verified they bot were functioning properly.Siemens engineer and the biomed engineer at the customer site were unable to reproduce the described incident.No malfunction of the footrest was determined at the affected site.It is assumed that the foot rest was not properly attached by the user.Internal id # (b)(4).

Event Description

Siemens became aware of an incident on the luminos agile max unit.The foot rest became unlodged during a patient exam.As a result, the patient dropped one inch to the floor.The operator was able to reattach the foot rest and continue with the examination.There are no injuries attributed to the event.

Manufacturer Narrative

H10 manufacturer narrative: as previously reported, siemens local service inspected the system and the footrest and verified both were functioning properly.The siemens engineer and the biomed engineer at the customer site were unable to reproduce the described incident.The footrest did not malfunction, and it was assumed that the footrest was not properly attached by the user.Based on the available information it is assumed that the footrest could become detached due to improper use or incorrect attachment of the footrest.If the footrest is not attached properly, it can become loose during patient operation.Therefore, it is recommended to check the footrest again before each use to ensure it is properly secured.The correct attachment and use of the footrest is described in the user manual (see xpd1-325.620.01.01.02, register 8: accessories and auxiliary devices, page 28/29 - footrest).To further improve the understanding of the handling of the footrest, the description in the user manual will be updated in future versions of the operator manual.Additional details and illustrations on how to securely attach the footrest are and will be provided with: an addendum for series production (released on 25.11.2022), an addendum for the installed base (released on 06.12.2022 via xp051/22/s), and the new version of the operator manual (final release planned for end of december 2022).The complaint has been closed.Further action by siemens is being addressed via xp051/22/s.H11 corrected data: b1, b2: adverse event and other serious or important medical events were checked in error in the initial report submitted on january 1, 2022.Product problem should have been checked.H1: "malfunction" should have been checked on initial report since there was no serious injury.G2: report source should have been "health professional" as this was not a user facility mdr.

• Brand Name: LUMINOS AGILE MAX
• 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; 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: 13313972
• MDR Text Key: 284172308
• Report Number: 3004977335-2022-12829
• Device Sequence Number: 1
• Product Code: JAA
• UDI-Device Identifier: 04056869009162
• UDI-Public: 04056869009162
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10762472
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 159 KG