MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON 18L6 HD LINEAR ARRAY 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 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to siemens for evaluation.If additional information is received or if the device is returned at a later date, this report will be supplemented.

Event Description

It was reported that the 18l6 hd transducer displayed a 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

The device referenced in this report was returned for evaluation.S-family hsc confirmed that this issue occurred on vd10c and no evidence could be found that the issue was recurrent or went away after transducer replacement, it is likely that this issue was caused by the initialization issue with the sw vd10x.This issue was investigated via plm defect 483014 and resolved in ve10a, via eco# 649637 released on 02 mar 2017 from plm defect 483014: the root cause of the triple images is an initialization issue when the transducer is selected, which occurs roughly 1 in 1000 probe initializations.The interim solution would be to look for the triple image when the transducer is selected, which can be done by pressing a finger on one end of the transducer, and making sure the image is as expected, i.E.You can see one finger on the image.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.

• Brand Name: ACUSON 18L6 HD LINEAR ARRAY 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: 6457989
• MDR Text Key: 71697138
• Report Number: 3009498591-2017-00126
• 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: 07/28/2017

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: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2016
• 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