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

Model Number 10094200

Device Problem Mechanical Problem (1384)

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

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported incident.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

Following a patient examination, the table of the axiom luminos drf dropped down and hit the floor.The provided picture showed that the table hit the floor on one end.The table was slightly tilted.The incident occurred after the patient left the room.There was no injury reported neither to the patient nor to the operator.The reported incident occurred in (b)(6).

Manufacturer Narrative

The investigation of the log files showed a system error detected by the software.A potentiometer problem with the "tablelift" axis was recognized several times before the collision.Thus, the drive was blocked until the error rectification or system restart.No system movement is possible with the potentiometer issue as the collision calculation is disabled and, therefore, the system can only be moved in safety mode at a very slow speed and with a warning signal.A failure message is displayed to inform the operator.By confirming the failure message, the user can further operate the system for the current procedure.This was confirmed by the analyzing the available log files.However, the user may take over the active collision control, making it user's responsibility to avoid objects when moving the system.The safety run mode is only intended for patient rescue and service must be called following procedure completion (see also user manual axd3-500.620.02.02.02 page 136/137).Based on the investigation results, the system was intentionally moved by the operator in the safety mode until the table frame hit the floor.According to the local service organization, following parts were replaced on the affected system: microswitch 1co 250v 6a qc 6,3 (material number 1070721), master drive assembly (material number 7033553) and the potentiometer 1k 1.5w 10% l.25%10g (material number 7755531).For all these components the spare part consumption was checked and it show values below the defined thresholds.The investigation showed that only the potentiometer could have caused the occurrence of the described issue.Both other parts could not be determined as cause of this issue.After replacement of parts no further issues are known from customer site.

• 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: 11728310
• MDR Text Key: 247498498
• Report Number: 3004977335-2021-77368
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094200
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 05/05/2021
• Supplement Dates FDA Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other