MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM EMOTION 16; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	8098027
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was manufactured in 2007.Siemens has initiated a technical investigation of the issue to identify the root cause.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported to siemens that the gantry drive belt of the somatom emotion 16 system was broken during a patient scan.The torn belt crashed through the cover of the ct scanner scan window and hit the patient's legs.There was no reported patient injury; however, in a worst-case scenario, patient injury cannot be excluded if the event were to reoccur.The reported event occurred in the (b)(6).
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.Unfortunately, the root cause could not be determined.During the hardware investigation of the broken belt the root cause could not be determined.The belt shows abnormalities in several places and a large number of these are present in the area of the fracture.The different types of damage found can have various causes.Based on this, the reason for the belt breakage could not be clearly determined.Tensile strength was tested and met the specification.A decrease in mechanical strength or a change in elongation at the break could not be detected.Two weeks after replacement of the belt and the idle axle, the system was checked and no wear/abrasion was found on the new idle axle and belt.No further actions are to be taken as there is no negative awareness regarding the quality and performance of the affected component and no general design issue was identified.

• Brand Name: SOMATOM EMOTION 16
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843231631
• MDR Report Key: 13253034
• Report Number: 3004977335-2022-10590
• Device Sequence Number: 4520419
• Product Code: JAK
• UDI-Device Identifier: 04056869013114
• UDI-Public: 04056869013114
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K050297
• 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,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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: 8098027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 08/03/2022
• 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
• Patient Sex: Unknown