MAUDE Adverse Event Report: MULTIX FUSION; STATIONARY X-RAY SYSTEM

Model Number	10746665
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to post-market surveillance data for multix fusion, siemens is not aware of any similar occurrences in the field.The user was instructed to stop the device use until repairs.According to the provided information, siemens local service engineer visited the concerned site and lifted the two 3d stand wheels back onto the rails; he re-installed and tightly secured the end stoppers including the front transverse cover.The system was returned to the customer fully functional.Siemens is conducting an investigation of the reported event.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).
Event or Problem Description
During a service call, siemens became aware of an event occurred on the multix fusion unit.The incident occurred with the transverse carriage.When the user moved the 3d stand transversely to align the tube to a wall stand, the front cover on the transverse carriage fell down to the floor with two end stoppers and the two of the 3d stand wheels ran off the rails track.This resulted in the 3d stand being stuck with no further movement possible.There are no injuries attributed to the event.The reported incident occurred in (b)(6).
Additional Manufacturer Narrative
Siemens completed investigation of the reported issue.It was determined that the root cause of the reported event is improper system installation caused by individual workmanship error.No further activities are necessary to the overall installed base.To improve awareness of the mandatory step during system installation in order to avoid similar issues in the future, the installation instructions and maintenance docs will be optimized according to siemens internal change process.

• Brand Name: MULTIX FUSION
• Common Device Name: STATIONARY X-RAY SYSTEM
• MDR Report Key: 11575289
• Report Number: 3004754211-2021-70617
• Device Sequence Number: 4266387
• Product Code: KPR
• UDI-Device Identifier: 04056869019888
• UDI-Public: 04056869019888
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K121513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 10746665
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 05/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other