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

Model Number 11327600

Device Problem Break (1069)

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

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

The system was brought back to specifications.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 occurred on the artis icono biplane system.A large display was moved, and it collided with a plane flat detector.As result the large screen protector shattered.Siemens service engineer was able to remove large pieces of glass, and the user removed smaller shards from inside the ld frame.There are no indications of any adverse effects on the health status of the involved persons.Siemens has requested additional information in order to conduct an investigation of the reported event.

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, log file analysis, and cc-part analysis.As initially reported, after a procedure the detector of plane a collided with the large display whereby the protection glass of the large display shattered.Most of the shattered glass remained in the frame of the protection shield and did not fall.Only small glass shards from the impact point fell onto the cover of the detector and onto the lower rim of the display.X-ray was still available, stand movement was still possible in override mode.There were no indications of any adverse health effects to the involved persons.According to log file analysis, the collision was caused by moving the dcs with the large display against the detector.The collision happened during user-controlled system movement.There is no indication for an unintended movement of the system.The operator manual contains adequate instructions about system movement and how the operator can avoid a collision with not-collision-monitored components (e.G., display ceiling suspension or mobile equipment).The large display was replaced as part of service activity, which resolved the problem.Impact tests were performed on the replaced part by the oem manufacturer.According to provided test report, one monitor had broken glass after the test, but no cracked glass fell off.Test results comply with the required standards.A possible general error that would require corrective measures of the installed base could not be determined by the investigation.The complaint was closed.

• Brand Name: ARTIS ICONO BIPLANE
• 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: 16273074
• MDR Text Key: 309064251
• Report Number: 3004977335-2023-60860
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11327600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2023
• 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