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 Consequences Or Impact To Patient (2199)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report was returned to siemens for evaluation.The reported phenomenon of triple image artifacts may have been caused by amb electrical malfunction or coax cable damage.During system test, image dropout was observed.It was found that the mpt2-3 inductor board had detached from the mp connector socket due to insufficient sealant.After inserting mpt2-3 inductor board in the slot and re-assembly, the image dropout disappeared.The possible root cause of the reported phenomenon was insufficient adhesive during manufacturing.As a corrective action, relevant operators have been retrained in the procedure.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

During review of service notifications, it was found that the 18l6 hd transducer generated a triple image artifacts during a 2d scanning.According to a patient follow-up report, the customer would have re-initialized the transducer to resolve the issue and complete the intended study.There was no loss of data and there was no patient adverse event reported.No additional information was provided.

Manufacturer Narrative

For this complaint, when it was originally received on 09/07/16, 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: 6456775
• MDR Text Key: 71732595
• Report Number: 3009498591-2017-00143
• 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: 10041227
• 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: 06/10/2014
• 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