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 09/06/2021

Event Type  malfunction  

Event Description

It was reported to siemens that an infant patient had to undergo a second topogram scan (low dose overview scan) due to a system malfunction during the use of the reported somatom definition flash system.Aside from the additional x-ray dose, there was no report of adverse event or injury sustained by the patient due to the necessity of the second scan.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 reported issue was attributed to, and was resolved by, replacement of the following parts: cu rot - pn / 10183882.Tx module rotation - pn / 10183874.Rx module rot - pn / 10183880.After replacement of the listed parts, the system was brought back to clinical operation.(b)(4).No general product design issue has been identified.Further investigation within the complaint process is not deemed necessary.

• 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: 12561696
• MDR Text Key: 283829092
• Report Number: 3004977335-2021-96067
• 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
• Report Date: 10/01/2021

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: 09/06/2021
• Initial Date FDA Received: 10/01/2021
• 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: 29 DA
• Patient Weight: 4