MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEE III CEILING; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10502502

Device Problem Mechanical Problem (1384)

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

Event Date 07/08/2023

Event Type  malfunction  

Manufacturer Narrative

H10: additional manufacturer narrative: e1: a customer contact name and telephone number were not provided for reporting purposes.G4: the artis zee iii ceiling system is not marketed in the united states.The 510(k) number provided is for artis zee, a similar product marketed in the united states.H3, h6: siemens has initiated a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplemental report will be filed if additional information becomes available upon completion of the investigation.

Event Description

A siemens customer service engineer (cse) informed the manufacturer that the steel frame ceiling suspension structure used to mount the rails of the ceiling stand for the artis zee iii ceiling system is not stable.Detailed clarification and additional information have been requested and are pending receipt.There was no indication of any adverse health effects of the involved patient or others due to this event.

Manufacturer Narrative

H3, h6: siemens completed the detailed investigation of the reported event and system.The investigation was performed based on expert discussions considering the complaint description, customer service reports, and system history.According to the initially provided information, the user recognized a loud noise during ceiling stand movement and informed siemens service.The onsite service inspection showed a faulty weld seam on the external steel frames which are used as the suspension structure (not part of the artis system) to mount the two rails of the ceiling stand.The ceiling rails are slightly tilted in this position.According to provided information there was no risk that the ceiling stand could fall due to the faulty weld seam.The external steel frames are not part of the artis system.Therefore, no problem related to the artis system is identified.The system works as specified.The problem will be handled by the respective responsible party.

• Brand Name: ARTIS ZEE III CEILING
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17388072
• MDR Text Key: 319787247
• Report Number: 3004977335-2023-00065
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10502502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1