MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON S3000 ULTRASOUND SYSTEM; ULTRASOUND DEVICE

Model Number ACUSON S3000 MAINFRAME

Device Problems Signal Artifact/Noise (1036); Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2017

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 generated an intermittent triple image artifacts during a thyroid procedure.The user removed the transducer and a replacement transducer was activated to continue and complete the procedure.There was no loss of data and there was no patient adverse event reported.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide additional manufacturer narrative.Engineering investigated the issue and found that 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.This issue was resolved in ve10a, via eco# (b)(4) through plm defect (b)(4).

• Brand Name: ACUSON S3000 ULTRASOUND SYSTEM
• 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: 6540775
• MDR Text Key: 74317327
• Report Number: 3009498591-2017-00191
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUSON S3000 MAINFRAME
• Device Catalogue Number: 10441730
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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