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

Model Number 10590000

Device Problem Image Display Error/Artifact (1304)

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

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter's phone number is (b)(6).Siemens completed the technical investigation of the reported event.The artifacts were determined to be motion artifacts.Furthermore, the user had increased the scan speed (pitch) and rotation speed within the optimized default scan protocols for children, resulting in less projections during the scan.Therefore, the event is considered a user error.No general design issue was identified.No remedial actions will be initiated.

Event Description

It was reported to siemens that during a contrast enhanced ct chest scan of an 11-day old infant patient, blurry artifacts were observed on the ct image.The infant was sedated and intubated during the procedure.Due to the severe artifacts, a diagnosis was not possible.Afterwards, an ultrasound examination was required for the diagnosis.There were no negative health consequences to the infant reported to siemens with exception of the x-ray dose and contrast media administered without clinical benefit.The reported event occurred in (b)(6).

• Brand Name: SOMATOM DEFINITION EDGE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486484
• MDR Report Key: 10818116
• MDR Text Key: 220743297
• Report Number: 3004977335-2020-51028
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006949
• UDI-Public: 04056869006949
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10590000
• Device Catalogue Number: 10590000
• Device Lot Number: 83509
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/14/2020
• 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: 11 DA