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

Model Number 10430603

Device Problem Unexpected Shutdown (4019)

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

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens has initiated a technical investigation of the reported event.The root cause has not been identified and it is unclear if the system malfunctioned.A supplemental report will be submitted upon the completion of the investigation.

Event Description

It was reported to siemens that during a contrast enhanced ct scan of a (b)(6)-month old infant with the somatom definition flash system, the scan aborted in the middle of the scan.The parent was standing next to the gantry during the examination, when this issue occurred.After a reboot of the scanner, the examination could be continued.Consequently, the child was rescanned, and additional 7 ml of contrast media was given.After the ct examination, a 4-hour saline drip needed to be given to the patient in order to flush contrast.No other injury of the patient has been reported except the additional xray dose, contrast media and need for the saline drip.This report has been submitted with an abundance of caution.

Manufacturer Narrative

Siemens completed the technical investigation of the reported event.The root cause of the event was identified as a use error which was found by the siemens developer after investigating the event logfiles.The spiral scan after monitoring scans was aborted due to an incorrect htp position information in readings because patient table step plate, between the gantry and phs, was pressed.It was released approximately two minutes after the scan abort.No device malfunction has been identified.

• Brand Name: SOMATOM DEFINITION FLASH
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10507425
• MDR Text Key: 220733978
• Report Number: 3004977335-2020-42304
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• 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,Followup
• Report Date: 11/10/2020

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
• Device Operator: Health Professional
• Device Model Number: 10430603
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Weight: 4