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

Model Number 7008605

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/29/2022

Event Type  Injury  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.

Event Description

Siemens became aware of an incident that involved the axiom artis dta system.While transporting a patient, the iv pole was positioned too high; it caught cables and pulled the trolley out of the track.Additional information was received that an operator was struck as a result of this incident.No further information regarding health consequences was communicated.

Manufacturer Narrative

H10: manufacturer narrative: siemens healthcare completed the investigation of the reported event.The investigation was performed based on expert discussions considering the complaint description, customer service reports, system history, and system log files.According to the available event information, the infusion pole was pulled after it got caught in the display ceiling suspension (dcs) cables, and as a result, a cable trolley fell.The cable trolley cannot fall completely because it is still attached to the wiring harness that hangs in loops from the ceiling.However, one staff member was hit by the carrier, but was not injured.The investigation revealed that one (1) of the three (3) cable carrier wheels was broken, which caused the carrier slip out of the rail.This kind of issue could occur when forces perpendicular to the movement direction are applied, as in the present case.The issue was solved by replacing the cable trolley.The occurrence rate of the was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.H11 corrected data: h3: device had not been evaluated by manufacturer when the initial report was submitted on december 27, 2022.This field should have been checked "no" in the initial report.H6: component code was corrected.

• Brand Name: AXIOM ARTIS DTA
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1 or rittigfeld 1; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 16051286
• MDR Text Key: 306167832
• Report Number: 3004977335-2022-54955
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7008605
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other