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

Model Number	10594738
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is highly recommended to have an alternate backup system available.Investigation is on-going.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).
Event or Problem Description
Siemens became aware of an incident with the mobilett mira max mobile x-ray unit.A newborn in fragile state of health was being imaged on the device.After the first image was taken and a lateral image was about to be performed, the system displayed an error message; the examination could not be completed on the concerned unit.However, it was not necessary to use a backup system as the user was able to make diagnosis using the first image.No lasting impairment of the newborn was communicated; however, the user was concerned about delay of the procedure.The reported incident occurred in (b)(6).
Additional Manufacturer Narrative
The investigation of the provided log files showed that the error 62/81 ("fw mismatch between d812 and d832") occurred only once and was not reproducible.Investigating the data from installed base related to the mentioned issue does not indicate a systematic issue.The affected boards d812 and d832 have been requested for a detailed investigation.According to the information received, the user did not accept replacement of the boards as the system software was reinstalled (b)(6), 2022, and the reported issue has not reoccurred.Therefore, a detailed root cause analysis could not be performed.However, siemens recommended to replace both boards d812 and d832.According to the experts, this type of problem may have been caused by a timeout issue from components, which handle the communication between both boards.The described issue is not known as a systematic or general problem.

• Brand Name: MOBILETT MIRA MAX
• Common Device Name: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 13422666
• Report Number: 3004977335-2022-14493
• Device Sequence Number: 5893235
• Product Code: IZL
• UDI-Device Identifier: 04056869009131
• UDI-Public: 04056869009131
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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: 01/27/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 05/09/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown