MAUDE Adverse Event Report: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. ARTIS ONE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10848600
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
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 with the artis one system.It was reported that part of the ceiling connected to the dcs peeled off from its inner base and the entire dcs mounting fell to the floor.The incident occurred at night and no one was in the room.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 workmanship error.The investigation showed that the ceiling construction in the hospital was not able to load the dcs, which led to a broken ceiling structure in which the dcs fell off.The ceiling construction and pre-installation kit mounting to the ceiling was specifically performed by the construction contractor in poland.Siemens defined the requirement that the dcs was required to be fixed on the solid concrete ceiling with min.160mm thickness and provided the requirement to the construction contractor via installation guidelines.The contractor did not follow the requirement and mounted the pre-installation kit for the dcs mounting based on the air block position instead of concrete position of the ceiling.The dcs function was checked and the dcs was re-fixed to the ceiling with extra metal sections.Additionally, siemens has updated the local (poland) procedure to require that the construction drawing provided by the construction contractor be verified or issued by an authorized construction designer.

• Brand Name: ARTIS ONE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; siemens mri center, gaoxin c; hi-tech industrial park; shenshen, china 51805 7; CH 518057
• Manufacturer (Section G): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen, china 51805 7; CH 518057
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 6104486461
• MDR Report Key: 12432551
• Report Number: 3004754211-2021-95038
• Device Sequence Number: 3421012
• Product Code: OWB
• UDI-Device Identifier: 04056869009964
• UDI-Public: 04056869009964
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K133580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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: 10848600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 11/09/2021
• 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