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

Model Number 8098027

Device Problem Unexpected Shutdown (4019)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens conducted a thorough technical investigation of the reported event.The siemens customer service engineer determined during the inspection of the reported system that the main breaker, including inverters f1 and f2, in the power distribution cabinet were tripped and the inverters f1 and f2 had malfunctioned.After the breaker was reset and the affected inverters replaced, the system was returned to operation.The material consumption in relation to the installed base is monitored by the capa process (values for the last 3 months) are presented in the following: mat# 10662932 - service part matrix inv nub - march 2021: 0,02%, february 2021: 0%, january 2021: 0.04%.No further investigation within the complaint process is necessary.No general product issue has been identified.

Event Description

It was reported to siemens via receipt of user facility mdr (b)(4), that the somatom definition as scanner shut down during a contrast enhanced ct cardiac examination (dilated aortic root.Follow-up of marfan's syndrome).The ct gated thorax was scanned with two-thirds of the heart only visualized due to the scanner shutting down.Imaging was processed up to the point of the shut-down.Although the patient study was sufficient, it is considered incomplete due to the portion of the heart missing from the study.The radiologist reviewed the study and notified the physician of the results.The patient was sent home with no complaints.There was no patient injury or adverse event reported.The patient did not have to be rescanned.However, in a worst-case scenario, a rescan might become necessary since the planned scan volume was not completely captured when the scan aborted.

• 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: 11876757
• MDR Text Key: 252398162
• Report Number: 3004977335-2021-78978
• 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: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• 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: 04/28/2021
• 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: 39 YR
• Patient Weight: 83