MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MOBILETT MIRA MAX; MOBILE X-RAY SYSTEM

Model Number	10594738
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is on-going.A supplemental report will be submitted if additional information becomes available.(b)(6).
Event or Problem Description
Siemens was informed about potential risk with the mobilett mira max system.The metal mounting plate of the collimator broke at the bending part of the handle, when the collimator was used to position the tube over the patient.The collimator cover was dangling; however, no falling parts were communicated.No injuries are attributed to this case.
Additional Manufacturer Narrative
The issue was investigated in detail and based on information from similar cases.The collimator cover is fixated by four screws on two holders, which are part of the collimator.The mounting brackets are produced with steel sheet metal bent to 90° with the addition of four threaded inserts.The housing is mounted to these four threaded inserts.Upon investigation, it was discovered that the sheet metal had been bent two times in opposite directions, thus weakening the piece.As a result, the sub supplier was changed.Furthermore, the design was modified to ensure additional strength of the piece; visual checks were implemented to ensure the piece was neither broken nor bent two times.These mentioned improvements on the brackets have been already introduced by the supplier for collimators used for mobilett elara units, starting with serial number (b)(6) (in combination with collimator serial number (b)(6)).This collimator is used on two system types with different part numbers.Mobilett mira max (10519819), mobilett elara max (11364066).According to the user manual (xpr8-270g.620.03.01.02, page 123), the user must perform a daily check of function and security.If damaged or loose parts are found, the system may not be used until repair was performed.The described issue was resolved at the concerned customer site by siemens local service technician replacing the affected part.

• Brand Name: MOBILETT MIRA MAX
• Common Device Name: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; forchheim, 91052 ; GM 91052
• MDR Report Key: 10420233
• Report Number: 3002808157-2020-41915
• Device Sequence Number: 2942735
• Product Code: IZL
• UDI-Device Identifier: 04056869009131
• UDI-Public: 04056869009131
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other