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

Model Number	10594738
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The concerned tube fork was replaced by siemens local service.The investigation is ongoing a supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).
Event or Problem Description
Siemens local service reported that allen head screws on the tube fork of the mobilett mira max were found to be broken.In worst case, if the tube fork becomes detached, a person may be hit by the falling tube, resulting in a minor to a serious injury.No injury or patient involvement was communicated in this case.
Additional Manufacturer Narrative
The issue was investigated in detail.The returned tube fork was investigated at the supplier.The investigation showed that the fork brake was missing, which resulted in the described issue.There are two brakes on each side of the tube fork, where the single tank is attached, to stop the rotation.One of the brakes was missing for the reported issue.There are also two screws that limit the rotation of the single tank.With one brake missing, the rotation of the single tank was easier to perform as designed.Therefore, if the operator tried to rotate the single tank too fast or with too much force, the screw heads would receive a greater impact, which could cause the screw heads to be cut off.However, the cause of the missing brake could not be identified.It was also detected that the "brake adjustment" screw was overtightened, which means that this screw might have been modified during a previous service.The investigation showed that there was no risk of the tube fork detaching from the system completely.According to the information from the service organization, the issue was resolved by replacing the fork.The spare part consumption of this part (10656692) shows values below the defined threshold.This issue is not known as a systematic or general problem since it is the first known case.In general, the single tank movement shall be checked every day by the operator before using the system to prevent further damages.This is also described in the operator manual xpr8-270g.620.03.01.02, page 123.

• 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: 12127711
• Report Number: 3004977335-2021-87137
• Device Sequence Number: 17253336
• Product Code: IZL
• UDI-Device Identifier: 04056869009131
• UDI-Public: 04056869009131
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 12/14/2021
• 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