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

Model Number 10762472

Device Problem Mechanical Problem (1384)

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

The concerned footboard was replaced by siemens local service.The investigation is on-going a supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

It was reported that one of the four metal tips used to attach the footboard to the luminos agile max device was missing.This caused the footboard to wobble.No injury or patient involvement was communicated in this case.

Manufacturer Narrative

The issue was investigated in detail.The investigation of the provided pictures and the received information showed that the missing tip has no impact to the safety use and attachment of the foot support.The plastic tip improves slipping of the foot support at the tabletop.The safety use and the attachment of the foot support at customer site was checked and confirmed by a local service technician.However, since the customer had concerns about the safety, the foot support was exchanged.With the new foot support, the wobbling appeared to be less.Due to tolerances in the tabletop and foot support, parts with maximum tolerance may have more play than in general when they come together.This could give the user the impression that the parts were wobbling and not safe for use.Since the replaced foot support was already scrapped at the concerned customer site, there was no possibility to get this part for a deeper root cause analysis.Therefore, the cause of the issue could not be determined.

• Brand Name: AXIOM LUMINOS AGILE MAX
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 12224865
• MDR Text Key: 263395062
• Report Number: 3004977335-2021-89792
• Device Sequence Number: 1
• Product Code: JAA
• UDI-Device Identifier: 04056869009162
• UDI-Public: 04056869009162
• Combination Product (y/n): N
• PMA/PMN Number: K111292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10762472
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other