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

Model Number 10746665

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 03/01/2021

Event Type  malfunction  

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 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).

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
• Type of Device: STATIONARY X-RAY SYSTEM
• MDR Report Key: 11575289
• MDR Text Key: 280460183
• Report Number: 3004754211-2021-70617
• Device Sequence Number: 1
• Product Code: KPR
• UDI-Device Identifier: 04056869019888
• UDI-Public: 04056869019888
• Combination Product (y/n): N
• PMA/PMN Number: K121513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 10746665
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/26/2021
• Supplement Dates Manufacturer Received: 05/24/2021
• Supplement Dates FDA Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other