MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON X300 PE ULTRASOUND SYSTEM; ULTRASOUND DEVICE

Model Number ACUSON X300 PE

Device Problem Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 12/19/2015

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.Follow-up narrative: this supplemental report is being submitted to provide additional event information, correct the patient code and provide additional manufacturer narrative.Multiple attempts were made to obtain additional information and patient outcome but with no results.Note: the original emdr was submitted to the non-production environment.This report is to submit to the production environment.All original files are attached.This emdr contains both the initial and fu#1.

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.During review of the service report, it was reported that the user smelled smoke and the system will not power up.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 X300 PE 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
• MDR Report Key: 6655385
• MDR Text Key: 281428661
• Report Number: 3009498591-2016-00417
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• PMA/PMN Number: K121699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• 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: 06/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUSON X300 PE
• Device Catalogue Number: 10348531
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2016
• 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