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

Model Number 10594738

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.A supplemental report will be submitted if additional information becomes available.(b)(6).

Event 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.

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
• Type of Device: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; forchheim, 91052 ; GM 91052
• MDR Report Key: 10420233
• MDR Text Key: 203319459
• Report Number: 3002808157-2020-41915
• Device Sequence Number: 1
• Product Code: IZL
• UDI-Device Identifier: 04056869009131
• UDI-Public: 04056869009131
• Combination Product (y/n): N
• PMA/PMN Number: K111912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10594738
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other