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

Model Number	11107444
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The concerned unit is still operational.The user taped the knobs back onto the shaft as a workaround until the knobs are replaced by cse as already planned.The investigation is on-going.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).
Event or Problem Description
The user of the mobilett elara max informed siemens that the collimator knobs detached from the machine while preparing to take an exposure in a sterile environment.There is no injury attributed to this event, however, collimator knobs falling into a sterile environment may result in an infection to a person.
Additional Manufacturer Narrative
The issue was investigated in detail.It is assumed that two factors led to the breakage of the collimator knobs (material number 11363999).First, there were frozen tensions within the used plastic of the collimator knobs due to the manufacturing process.Secondly, and this was confirmed by the service organization, there must have been an incorrect handling of the knobs by the operator.However, the exact cause could not be determined.The combination of both those factors caused the breakage of the knobs.During the investigation it was also identified that the used knobs have been of the older version without the improved inlay.In the past the inlay has been improved to make the collimator knobs more robust.The improved knobs are already introduced in the factory and available as spare parts with material number 11363999.On site the issue was resolved by local service by replacing the broken knobs with the newer version.Due to al high spare part consumption rate and changes in the manufacturing process not showing the expected results, further modifications of the collimator knobs are undertaken.This further improved version will be available as spare part for the installed base in (b)(6) 2022.

• Brand Name: MOBILETT ELARA MAX
• Common Device Name: MOBILE X-RAY SYSTEM
• MDR Report Key: 12134942
• Report Number: 3004977335-2021-87665
• Device Sequence Number: 14602765
• Product Code: IZL
• UDI-Device Identifier: 04056869154992
• UDI-Public: 04056869154992
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K182639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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: 11107444
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 10/15/2021
• 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
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other