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

Model Number ACUSON S3000

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/10/2016

Event Type  malfunction  

Event Description

It was reported that the keyboard bezel has a large crack with a sharp edge near the dgc panel.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.

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 provide the date new information was received.Additional information was received and it was reported that the phenomenon was noted during equipment testing/preventative maintenance.There was no study being performed so there was no patient involvement.No additional information was provided.Follow-up #2 narrative: this supplemental report is being submitted to provide the date new information was received by manufacturer and provide the type of report; provide the type of reportable event; provide the type of follow-up, and update the event problem and evaluation codes; and provide the investigational results.The device referenced in this report was not returned to siemens for investigation; however, the customer service engineer (cse) was onsite and visually saw that the bezel was cracked.The cse replaced the defective bezel.The control panel cracking was attributed to the product design.It was addressed with a design change to the plastic components of the control panel, implemented in october 2016.(b)(4).Note: the original emdr was submitted to the non-production environment.This report is to submit to the production environment.This emdr contains the initial submission, fu#1 and fu#2.

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 10/05/16.Additional information was received and it was reported that the phenomenon was noted during equipment testing/preventative maintenance.There was no study being performed so there was no patient involvement.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide additional event information (see section b5), and provide the date new information was received (see section g4).

Manufacturer Narrative

This supplemental report is being submitted to provide the date new information was received by manufacturer and provide the type of report (see sections g4,g7); provide the type of reportable event; provide the type of follow-up, and update the event problem and evaluation codes (see sections h1,h2,h6); and provide the investigational results (see section h10).The device referenced in this report was not returned to siemens for investigation; however, the customer service engineer (cse) was onsite and visually saw that the bezel was cracked.The cse replaced the defective bezel.The control panel cracking was attributed to the product design.It was addressed with a design change to the plastic components of the control panel, implemented in (b)(6) 2016.Reference complaint (b)(4).

• Brand Name: ACUSON S3000 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: 7881100
• MDR Text Key: 283503022
• Report Number: 3009498591-2016-00385
• 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: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUSON S3000
• 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: 12/19/2016
• 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