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

Model Number	10594738
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens gained new awareness of this event december 2, 2020 through evaluation of a similar incident.A possible cause of the issue is weakening of the mounting bracket at the bends.This was caused by a non-systematic workmanship error during manufacturing of the bracket.Actions were performed to prevent the issue from reoccurring.The collimator was replaced at the affected site.The collimator is fixed with two mounting brackets.The breaking of one bracket will not result in the collimator falling off completely.In the unlikely event that both brackets break, the collimator fall would be prevented by the cables.Internal id # (b)(4).
Event or Problem Description
Siemens was informed about potential risk with the mobilett mira max system.Siemens local service reported that during service activities it was discovered that a collimator cover mount was broken on one side under the cover.No injuries are attributed to this case.

• Brand Name: MOBILETT MIRA MAX
• Common Device Name: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; erlangen, 91052 ; GM 91052
• MDR Report Key: 11019864
• Report Number: 3002808157-2020-41202
• Device Sequence Number: 13641446
• Product Code: IZL
• UDI-Device Identifier: 04056869009131
• UDI-Public: 04056869009131
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/16/2020
• 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