MAUDE Adverse Event Report: SOMATOM DEFINITION EDGE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	10590000
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight was estimated to be approximately (b)(6).Initial reporter is a siemens employee.A contact name for the facility was not provided.Siemens completed a technical investigation of the reported event.The investigation concluded that the user had the reconstruction boxes, which define the scan length, not aligned in the scan protocol.According to the siemens application specialist, the reconstruction boxes were no longer linked and the fast planning range was set to "none" for one reconstruction box (root cause).There was no malfunction of the reported device.The scan protocol has been corrected and saved to avoid reoccurrence.
Event or Problem Description
It was reported to siemens that the scan range of a (b)(6), male patient was longer than expected.Aside from the additional x-ray dose, there were no adverse health consequences to the patient.This report has been filed with an abundance of caution.

• Brand Name: SOMATOM DEFINITION EDGE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 12079983
• Report Number: 3004977335-2021-84264
• Device Sequence Number: 3910123
• Product Code: JAK
• UDI-Device Identifier: 04056869006949
• UDI-Public: 04056869006949
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K190578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2021

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: 10590000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 06/28/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 4 MO
• Patient Weight: 7