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

Model Number	1818363
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the event.It is stated in the operator manual to perform a daily check of the system.During the daily check loose parts should be noticed, and if so, service must be called.In case of system movements (e.G., to another place) the systems arm should be in locked position to avoid damages to the system / collimator.Normally the collimator and the cover would be held by cables should it detach completely from the system unexpectedly.Nevertheless, it is assumed that in worst case a minor to serious injury might be the outcome if a person were hit by a falling collimator.Investigation is ongoing.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).
Event or Problem Description
The screws holding the collimator cover on the mobilett xp units became loose over time.Personnel at the user's site took the cover apart and reinstalled without siemens involvement.However, the collimator remained unstable/wobbly.The collimator was unable to rotate to 180 degrees as designed.The inspection performed by siemens service engineer confirmed that the screws securing the collimator to the x-ray tube had loosened.Following cleaning and lubrication of the rotating parts, the collimator could be rotated normally again and became steady following the repairs.There are no injuries attributed to this event.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
The issue was investigated in detail.The investigation showed that the fixing screws of the collimator cover had become loose.The analysis of the provided pictures of the collimator did not indicate any issues on the collimator flange or on the related screws for the fixation of the collimator flange.The cover is fixed to the collimator with four screws.It is assumed that all four screws became completely loose and detached until the cover could completely fall off.According to the information received from the service organization, the problem was resolved by the user by retightening the screws on the collimator cover.It was determined that the last maintenance on the concerned system was performed in 2011.The customer does not have a service contract with siemens; therefore, it is possible that the screws got loose over time.It is recommended to perform a daily visual check of the system, such as of the collimator housing for loose or damaged parts (see also operator manual mobilett xp/xp eco/xp hybrid - spr8-230g.621.01.09, chapter "daily checks", page 95).Such functional and safety checks must be performed to ensure that the system is ready for operation and all safety-relevant unit functions are working properly.With this daily check the operator would also be able to detect a loose collimator cover.No general problem was identified.

• Brand Name: MOBILETT XP
• 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: 13869973
• Report Number: 3004977335-2022-20256
• Device Sequence Number: 17316356
• Product Code: IZL
• UDI-Device Identifier: 04056869009087
• UDI-Public: 04056869009087
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033238
• 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): 03/23/2022

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: 1818363
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 03/23/2022
• 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