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

Model Number 8098027

Device Problems Arcing (2583); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens completed a detailed technical investigation of the reported event.The root cause of the scan abort was an isolated x-ray tube arching incident.Siemens service experts performed a filament adaption (tube conditioning).The system has been functioning without error since the filament adaption was performed.Siemens did not identify a general design issue.Further investigation is not warranted at this time.

Event Description

It was reported to siemens that a scan abort occurred during a cranial ct scan of a (b)(6) patient.It was necessary to rescan the patient.Aside from the additional x-ray dose, there were no adverse health consequences.This report has been filed with an abundance of caution.

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 12023871
• MDR Text Key: 257396663
• Report Number: 3004977335-2021-82387
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: 04056869003665
• Combination Product (y/n): N
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8098027
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 5 YR