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

Model Number	1818363
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted if additional information becomes available.Internal id # pm00260540.
Event or Problem Description
Siemens became aware of an incident that occurred with the mobilett xp device.Due to a violent impact, the right side of the support arm has severe cracks, which may cause the tube to fall.The user was advised to isolate the unit and stop all usage until repairs are completed.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 of the replaced and returned fork for the single tank (10272848) showed that the fork was broken by a high mechanical impact.It is assumed that multiple collisions with the tube assembly led to the described damage of the fork.The broken fork indicates that the system was not used as intended.In the operator manual spr8-230.621.01.06., chapter transport page 47, it is stated to handle the fork/single tank with care and avoid collisions.The analysis of the material showed that the fork fulfilled the requirement of the four-fold fracture safety.According to the information received by the service organization, the system is fully functional following replacement of the defective part.The spare part consumption of the mobilett xp family fork for a single tank (material number 10272848) shows values that are below the defined threshold.

• Brand Name: MOBILETT XP
• Common Device Name: MOBILE X-RAY SYSTEM
• MDR Report Key: 11059498
• Report Number: 3002808157-2020-60540
• Device Sequence Number: 3260290
• Product Code: IZL
• UDI-Device Identifier: 04056869009087
• UDI-Public: 04056869009087
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/23/2020

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: 1818363
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 05/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other