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

Model Number 10849000

Device Problem Mechanical Problem (1384)

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

Event Date 12/22/2022

Event Type  malfunction  

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 a malfunction on the artis pheno system.The tooth belt of the table migrates from its original positions.This issue limita table movements, and may result in restricted treatment of the patient during a procedure.Siemens is unaware of any adverse effects on the health status of patients, users or third parties.

Manufacturer Narrative

H10: manufacturer narrative: h3, h6: siemens healthineers completed the investigation of the reported event.The investigation was performed based on expert discussions, consideration of the complaint description, customer service reports, system history, and system log file analysis.As initially reported, the artis pheno table transversal tooth rack migrates from its original position.In general, the toothed rack is glued to the rail.According to the investigation results there have never been any problems with the racks coming loose.The most likely root cause of the issue was the usage of an incorrect cleaning product that caused the toothed rack to come loose.Unfortunately, no information was provided regarding what disinfectant/cleaner was used and, therefore, the root cause could not be definitively determined.The system instructions for use contains information regarding which cleaning agents can and cannot be used.Contrary to the original assumption, the investigation revealed that system movements were not restricted, nor could the linear guiderails slide out.The table transversal toothed rack was exchanged by the local service organization.The issue reported in the complaint has not recurred and reported since the exchange.A possible general error that would require corrective measures of the installed base could not be determined by the investigation.After a thorough investigation, the reported issue is not classified as an adverse event a because neither serious injury, death, nor unexpected prolonged hospitalization of the patient or other person occurred or is to be expected, even if the issue recurs.

• Brand Name: ARTIS PHENO
• 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: 16184396
• MDR Text Key: 308832140
• Report Number: 3004977335-2023-58164
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201156
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10849000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2023
• 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