MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON S2000 ULTRASOUND SYSTEM; ULTRASOUND DEVICE

Model Number ACUSON S2000

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

Original submission narrative: this issue is under investigation.A follow-up report will be submitted when the investigation results are available.Note: the original emdr was submitted to the non-production environment.This report is to submit to the production environment.

Event Description

As a result of a recent fda inspection, we are retrospectively reviewing complaints and associated documents for compliance to the regulations from 2015 to date.We have strengthened our mdr reporting criteria and we are reporting the attached medical device report in accordance with our new criteria.As a result of this retrospective review, this mdr is being reported immediately upon discovery.It was reported that when taking a measurement, the system does not capture the assigned measurement at the designated image frame.The sonographer has to override it with a manual (physically choose the desired measurement) control, even then the system still does not always acknowledge the requested measurement label and defaults to a generic "d" measurement.When taking multiple measurements on the same image, the secondary requested set of measurements will default to a generic "d " measurement.Then when the sonographer goes to the next requested measurement, it is still hung up on the secondary portion of first request.If was further reported that if going out of protocol order, if sonographer opened the gb image frame and then bypass it, and then go to take the next measurement, system is still hung up on the last requested measurement (gb).When taking any volume measurements, the system always displays the "incomplete images notifications", at the end of exam, even though all requested images had been completed.The staff reported that these cause them to stop a lot, and add unnecessary time to the exams going back through to make sure they have not missed something.No additional information was provided.We are in the process of collecting patient outcome information, but due to our commitment to the fda, we are filing upon discovery of the potential adverse event before we have received patient outcome information.Unfortunately, due to the aware date, this information is not readily available and we are making every effort to obtain this information.Should we receive further information in regards to this event, we will file a follow-up report.

• Brand Name: ACUSON S2000 ULTRASOUND SYSTEM
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; business area ultrasound; 22010 se 51st street; issaquah WA 98029
• Manufacturer Contact: khalil thomas ; business area ultrasound; 22010 se 51st street; issaquah, WA 98029 ; 4253929180
• MDR Report Key: 6657675
• MDR Text Key: 282351847
• Report Number: 3009498591-2016-00429
• Device Sequence Number: 1
• Product Code: IYO
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUSON S2000
• Device Catalogue Number: 10041461
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• 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