MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON 18L6 HD ULTRASOUND TRANSDUCER; ULTRASOUND DEVICE

Model Number 18L6 HD TRANSDUCER

Device Problems Improper Device Output (2953); Output Problem (3005)

Patient Problem No Information (3190)

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was returned to siemens for evaluation.Visual inspection showed that the cable was kinked next to the strain relief.During system test, the image artifact was able to be reproduced.It was found a dual image artifact in the thyroid/musculoskeletal mode.When the cable which is next to the strain relief was bent, it affected the image.A noise was also detected in pw mode, indicative of a damaged coax cable, which is a possible root cause of the reported phenomenon.A review of the device history record (dhr) was performed and there is no information to indicate any non-conformance at the time of manufacturing process.

Event Description

It was found during the service review for safety that the 18l6 hd transducer displayed dropouts/triple image artifacts.No additional information was provided.Multiple attempts were made via email to obtain additional information regarding the reported phenomenon but with no results.

Manufacturer Narrative

For this complaint, when it was originally received on 03/23/16, it was classified as a non safety issue.A retrospective review for another malfunction was performed to look for all similar reports of a triple image symptom.This complaint was identified as having similarly reported symptoms and therefore it was decided to file an mdr.It was not until the investigation was completed did it become apparent that there were two root causes, one being hardware related and one being software related.The root cause of this specific complaint is related to a failure of the internal hardware components of the transducer and will present with a triplicate image, but the presentation of the image is very obvious to the user and would never be mistaken for one, continuous image.It is hardware related and also has different workflow steps to reproduce the issue compared to the software related failure mode.Based on these findings, this supplemental mdr is to correct the previously submitted reports which did not make this distinction clear.Based on these results, this product malfunction does not lead or have the potential to lead to serious injury or death.

• Brand Name: ACUSON 18L6 HD ULTRASOUND TRANSDUCER
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043 4050
• Manufacturer Contact: scott christiansen ; 685 east middlefield road; mountain view, CA 94043-4050 ; 4255571625
• MDR Report Key: 6456765
• MDR Text Key: 71698207
• Report Number: 3009498591-2017-00142
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K142876
• 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,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 18L6 HD TRANSDUCER
• Device Catalogue Number: 10789400
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2014
• 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