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

Model Number ACUSON S2000

Device Problem Loss of Data (2903)

Patient Problem Insufficient Information (4580)

Event Date 02/24/2016

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.Follow-up 1 narrative: this supplemental report is being submitted to provide additional event information, and to provide the date new information was received.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 as a follow-up to the original mdr submitted 10/03/2016.Additional information was received and it was reported that after an unknown procedure, it was found that the images were lost and were unrecoverable.The procedure was repeated.There was no patient or user injury reported.No additional information was provided.Follow-up narrative 2: this supplemental report is being submitted to update the device available for evaluation, update the follow-up type, update the device evaluated by manufacturer, update the event problem and evaluation codes, and provide the investigation results.Investigation: during the investigation of the complaint, the possible cause of the system loosing images when ending exam was a result of the user inadvertently deleting images from the review screen prior to ending the exam.This issue was resolved through the service process.Note: the original emdr was submitted to the non-production environment.This report is to submit to the production environment.This emdr contains both the initial submission, fu#1 and fu#2.

Event Description

It was reported that at the conclusion of the study, the patient's images were lost.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 a potential adverse event and without patient outcome information.Should we receive further information in regards to this report, we will file a follow-up report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional event information and to provide the date new information was received.

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 as a follow-up to the original mdr submitted 10/03/16.Additional information was received and it was reported that after an unknown procedure, it was found that the images were lost and were unrecoverable.The procedure was repeated.There was no patient or user injury reported.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to update the device available for evaluation (see d10), update the follow-up type (see h2), update the device evaluated by manufacturer (see h3), update the event problem and evaluation codes (see h6), and provide the investigation results.Investigation: during the investigation of the complaint, the possible cause of the system loosing images when ending exam was a result of the user inadvertently deleting images from the review screen prior to ending the exam.This issue was resolved through the service process.

• 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: 6443179
• MDR Text Key: 282963501
• Report Number: 3009498591-2016-00365
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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