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

Model Number 10094200

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Bruise/Contusion (1754); Injury (2348)

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

The system was checked by siemens local service and no issues could be identified.The investigation is still ongoing.A supplemental report will submitted if additional information becomes available.

Event Description

It was reported that a footrest on the axiom luminos drf became disengaged with a patient sitting on it.This failure caused the patient to fall on the ground.Minor injury - slight bruising - was reported in this case, however, no medical treatment was needed.The reported event occurred in (b)(6).

Manufacturer Narrative

Resubmission of initial report as per fda on 4/3/19.The provided photos were examined.The foot rest does not show any damages.Only usual signs of wear are visible that do not affect the functionality of the foot rest.It is concluded that the foot rest was not attached properly by the operator.Due to the various force effects while switching patients the foot rest became loose after some time and detached from the table.According to the operator manual it is operator's responsibility to check whether the foot rest is properly locked every time before allowing a patient to sit or stand on it.The correct attachment and handling of the foot rest is described in the operator manual (see xpd3-520.620.01.01.02 register 8; page 28-30).No system malfunction was identified in this case.

• Brand Name: AXIOM LUMINOS DRF
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr.1; forchheim, 91301 ; GM 91301
• MDR Report Key: 8510800
• MDR Text Key: 142525379
• Report Number: 3004977335-2018-48611
• 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: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• 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: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other