MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG MOBILETT MIRA MAX; SYSTEM, X-RAY, MOBILE

Model Number	10594738
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's preliminary results and conclusion: the mounting brackets are produced with steel sheet metal bent to 90° with the addition of four threaded inserts.However, in the reported case the sheet metal was bent twice in opposite directions, thus weakening the piece.Initial actions (corrective and/or preventive): the affected collimator was replaced with a collimator of new design provided by a different supplier (measures from previous complaint trend) and according to updated service documentation (replacement of parts) at the customer site.Currently no general problem has been detected for the installed base which requires an immediate action.Investigation is on-going.A supplemental report will be submitted to the fda if additional information becomes available upon completion of the investigation.
Event or Problem Description
Siemens became aware of an issue with the collimator on the mobilett mira max system.The collimator became loose as one of the two mounting brackets broke.However, the collimator did not fall off.Siemens is not aware of any injuries related to this issue.
Additional Manufacturer Narrative
E1: initial reporter state, north dakota, was added.H3, h6: siemens healthineers completed the detailed investigation of the reported issue.As previously reported, it was stated that a collimator screw mounting bracket was broken.The investigation confirmed that only one of the two collimator metal brackets broke.The analysis of the provided picture showed that the fracture occurred at the bent part.When this bracket is broken, the collimator cover screw will drift, and the collimator cover will become loose.However, the collimator cover was still fixed by two screws on the second holder and was not completely detached.Based on the investigation results the sheet metal was bent twice in opposite directions which weakened the piece and led to pre-damage.It was identified that the affected part (10519819) had an older design version of the bracket.A new version of collimator with an improved metal bracket design was released in january 2023.Shs internal post market surveillance does not indicate a general problem with this part.In general, the system user manual recommends that a daily safety check is to be performed to identify a loose collimator or damaged parts.In such cases the system may not be used until repair by service.The issue at customer site was already solved by service technician with replacement of the collimator.The complaint is closed with this statement.This complaint was closed without further measures.

• Brand Name: MOBILETT MIRA MAX
• Common Device Name: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1; -or- rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; malvern, PA 19355 ; 4843234198
• MDR Report Key: 19837480
• Report Number: 3004977335-2024-00089
• Device Sequence Number: 15100362
• Product Code: IZL
• UDI-Device Identifier: 04056869009131
• UDI-Public: (01)04056869009131
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K111912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 10594738
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2024
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 04/25/2025
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown