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

Model Number 10431700

Device Problem Unexpected Shutdown (4019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens has completed a technical investigation of the reported event.The investigation confirmed to a known issue with the turbo flash mode.The root cause was identified as an incorrect algorithm in the current software version and is being addressed and corrected as part of corrective action which has been reported to the fda (res 83377).This software issue is being resolved by application of software version vb20.The complaint system is scheduled for the vb20 update and will receive the software update soon.

Event Description

It was reported to siemens that a delay occurred during a ct bolus examination of a one-year old female patient.There was no reported injury to the patient due to the delay.Additional event details have been requested.In a worst-case scenario, the procedure would have to be repeated with additional contrast media and an additional x-ray dose.This report is being submitted with an abundance of caution.

• Brand Name: SOMATOM DRIVE
• 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 ; 4486484
• MDR Report Key: 9764698
• MDR Text Key: 195934379
• Report Number: 3004977335-2020-17712
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/30/2020

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: 10431700
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/27/2020
• 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
• Removal/Correction Number: Z-2271-2019
• Patient Sequence Number: 1
• Patient Age: 1 YR
• Patient Weight: 9