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

Model Number	10430603
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	07/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter's phone number is: (b)(6).Siemens completed a technical investigation of the reported event.There was no device malfunction.As previously stated, the patient's arms were not fixated during the examination as recommended in the system's instructions for use, print no.C2-029.620.16.03.02, pages 36, 37, 41 (root cause).No further investigation and/or remedial action is deemed necessary.
Event or Problem Description
It was reported to siemens that after a head examination of a patient using the somatom definition flash system, the patient's arm was fractured in a collision during patient table unloading (phs move-out).It was further reported that the patient's arms were not fixated during the examination.The patient's arm fracture was treated at the facility, but additional information was not made available to siemens.This report has been filed with an abundance of caution.The reported event occurred in (b)(6).

• Brand Name: SOMATOM DEFINITION FLASH
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 12143461
• Report Number: 3004977335-2021-87751
• Device Sequence Number: 17208382
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10430603
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2021
• Initial Report FDA Received Date: 07/09/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR