MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- AT AXIOM SIRESKOP SD, S3; STATIONARY X-RAY SYSTEM

Model Number 8890415

Device Problem Mechanical Problem (1384)

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

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

The exact root cause of the reported event at this point of time is unknown.A supplemental report will be submitted if additional information becomes available.Internal id# (b)(4).

Event Description

Siemens local service engineer reported to siemens that the table came in contact with the floor on the foot end.The incident occurred on the axiom sireskop sd unit while the table was being tilted from 90 to 0 degrees.Additional information was provided that the table had slid unexpectedly around the 30-40 degree mark.The foot-side safety bumper was then activated and successfully displayed an error message.No damage to the table occurred following the collision.The reported incident occurred before patient examination.No patient was involved in the incident.There are no injuries attributed to this event.

Manufacturer Narrative

The issue was investigated in detail.According to the received information, the system touched the floor while it was being tilted from 90° to 0°.During this procedure the foot end collision switch detached.The customer was able to recover the system by a reboot.Following this incident, the system could be tilted to 0° and the in-house engineer re-attached the collision switch.The service technician was able to reconstruct the situation at the customer site and provided pictures of the concerned system, which show the tilt angle and point of impact.The tilt angle was 30°-0° (other than the mentioned 75°-80° in the complaint).This fits the shown situation in the images.In this lower angle the impact is less intense as the mass of the system generates less acceleration.Since the collision switch was not destroyed and could be reattached by the customer, it can be concluded that the impact was not severe.The encoder board (d111) and the brake board (d12) were replaced, and all relevant connections were checked.The spare part consumption of both components shows values below the defined threshold.The encoder board (d111) converts the analogue signal from the potentiometer of the longitudinal drive into a digital can signal.If a malfunction occurs it might be possible for the drive to lose control for a short time.The brake board (d12) controls all motor brakes.The brakes act like parking brakes meaning that they are not able to stop a moving axle completely in all circumstances.Especially the system long axle can get a high velocity when it is accelerated by its own weight.When the drives are not in a fault condition, they get stopped by reversed current.The replaced parts were requested for a deeper analysis but could not be provided as these parts were no longer available.The investigation of the provided log files confirmed the described problems with the system tilt and system longitudinal drive just before the issue happened.The error descriptions indicates that there was a connection or communication error in the control circuit of the system longitudinal drive.The last entry before the issue happened says that the protection switch on the foot end was pressed (collision with floor).The reported event is considered a single occurrence at the customer site.Following part replacement, the system was tested with additional weight on the table and worked as specified.The system is fully functional again and no further issues are known.

• Brand Name: AXIOM SIRESKOP SD, S3
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10924620
• MDR Text Key: 219372570
• Report Number: 3004977335-2020-57149
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K051602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8890415
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other