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

Model Number 10094200

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the event.The user was advised not use the system any further until repairs are completed.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

An issue with the axiom luminos drf unit was reported.The tabletop of the system was deformed causing the fixing screws to come off.It is understood that some of the screws were retightened to keep the system operational.According to the provided pictures, the system has not been properly maintained; it is assumed that a possible collision may have caused the screws to come off.Potential risk of footrest detaching exists if the system is tilted to 90 degree position.This may lead to a patient falling or being hit with falling parts resulting in a minor to a serious injury.No injury or patient involvement was communicated in this case.The reported event occurred in (b)(6).

Manufacturer Narrative

The issue was investigated in detail.The investigation of the provided images showed that a collision with an obstacle had occurred during table lift/ tilt movement.This collision was on the foot end of the table and caused the described damage of the tabletop including loosening of the screws.According to the operator manual axd3-500.620.02.02.02 (chapter "safety" on page 32 / 374) it must be assured that neither persons nor objects are in proximity of lifting and rotating range of the patient table.According to the information from siemens local service organization, the system was repaired by replacing the whole tabletop.Following the replacement, the system works without further issues.

• 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
• MDR Report Key: 12084308
• MDR Text Key: 258991870
• Report Number: 3004977335-2021-86247
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K062623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094200
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other