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

Model Number	10094141
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis zee biplane system.The customer reports that the plastic collimator cover fell off when it flips upside down.The possibility exists that the cover could fall into the area of surgery.There is no report of impact to the state of health of any patient or user involved.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.The investigation was performed considering complaint description, cs reports, system history, and system log files.During a procedure the plastic cover of the collimator fell off and hit the floor.The falling part did not interfere with the procedure and no one was hit by the falling part.System movement as well as x-ray release were not affected by this.The failure happened approximately 12 years after installation of the cover.The customer service engineer (cse) investigated the system and exchanged the collimator cover.According to the system expert, a collision is the most probable cause.This resulted in the collimator cover becoming loose and subsequently falling down.It was not possible to conduct a more comprehensive investigation as pictures of the affected part could not be provided from the customer site.The system log files also contain information regarding collisions of the system.As the operator manual contains adequate instructions about system movement and how the operator can avoid a collision, no foreseeable misuse resulting from this user error is concerned.Therefore according to expert opinion a customer inattention could be determined as the most probable root cause.The spare parts consumption was checked.A possible general fault that would require corrective measures of the installed base could not be determined by the investigation.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: ARTIS ZEE BIPLANE
• Common Device Name: 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 ; 4843231631
• MDR Report Key: 13977317
• Report Number: 3004977335-2022-20369
• Device Sequence Number: 17496102
• Product Code: OWB
• UDI-Device Identifier: 04056869010069
• UDI-Public: 04056869010069
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K181407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection,Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10094141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown