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

Model Number	1818454
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of an incident with the mobilett xp unit.The collimator detached during an examination in the neonatal unit.This was caused by detachment of the flange that holds the collimator from the single tank.There was no injury attributed to the event.The reported incident occurred in (b)(6).
Additional Manufacturer Narrative
It is currently unclear whether the four screws holding the flange to the single tank became loose and what caused it.Further information was requested and the single tank, incl.The flange for attaching the collimator, was requested for investigation.It is stated in the operator manual to perform a daily check of the system.During the daily check loose parts would be noticeable and service must be dispatched.In case of system movements (e.G., to another place) the 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).
Additional Manufacturer Narrative
Additional information: d8: complaint system was not made available for evaluation.H8: usage of device added.H6, h10: the reported event was investigated in detail.The investigation was based on the provided pictures and information since the affected component was not available for investigation.It was confirmed that the return did not have the red cc-sticker and was therefore not marked as complaint part.The investigation showed that all four screws, which are used to fix the collimator flange to the single tank, were completely loose and out of the threaded holes.The four screws could only loosen over a long period of usage in combination with not tightening the screws and application of loctite.On the provided images of the screws, there were no clear indications showing that loctite was applied on the threads of the screws.In general, the factory is only using screws for the flange fixation on which the loctite is already pre-applied.This problem was not detected during maintenance or by the customer based on the requested daily checks.Maintenance was last performed during mid-june 2021.During this maintenance, the collimator lamp is normally replaced.During the replacement action the complete collimator cover must be removed, and a loose collimator fixation might be easy to detect.However, according to the maintenance protocol there were no abnormalities or malfunctions detected.Based on the spare part consumption of this system, the single tank (7742450) was replaced on march 23, 2022, for this replacement the collimator needs to be removed and fixed again on the collimator flange.In case the flange was re-used, the usage of loctite 243 for the four fixation screws is requested.The screws are also requested to be tighten with a certain force of 3.5 nm.In addition, based on the provided information, daily checks, described in user manual spr8- 230g.621.01.09 "operator manual mobilett xp hybrid", were not performed by the customer daily.During a daily check, a nearly loose collimator could be easily detected before completely falling.The complaint has been closed.Internal id# (b)(4).

• Brand Name: MOBILETT XP HYBRID
• 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: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 13976876
• Report Number: 3004977335-2022-21649
• Device Sequence Number: 5994542
• Product Code: IZL
• UDI-Device Identifier: 04056869009094
• UDI-Public: 04056869009094
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: 1818454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 07/14/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown