MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-AT AXIOM ARTIS DTA; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 7008605

Device Problem Mechanical Problem (1384)

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

Event Date 11/04/2021

Event Type  malfunction  

Event Description

It was reported to siemens that a malfunction occurred while operating the axiom artis dta system.When moving the display ceiling suspension (dcs), the user reported that the roller for the cable harness support fell off its track and hit a staff member in the head.We are unaware of any impact to the state of health of the user involved.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Manufacturer Narrative

The investigation revealed that one of the three wheel's bearing seal of the cable trolley was broken.This kind of defect occurs when forces perpendicular to the movement direction are applied.If the wheel is already defective in this way, the cable trolley finally can slip out of the guide rail, as it performs slight oscillating movements perpendicular to the direction of movement when the cable trolley is pulled.The cable trolley cannot detach completely as it is attached to the wiring harness that hangs in loops from the ceiling.Unfortunately, the investigation could not show a clear root cause retrospectively for the external forces damaging the wheel; according to the system experts, the most likely root cause is repeated extraordinary mechanical collisions with obstacles that might damage the cable trolley.This may result in a situation where the wheel broke out of the mounting bracket.The issue was resolved by replacing the cable trolley.The spare part consumption of this part is very low, so no general error has been recognized.

• Brand Name: AXIOM ARTIS DTA
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 6104486461
• MDR Report Key: 12786157
• MDR Text Key: 288027188
• Report Number: 3004977335-2021-03856
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7008605
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1