MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON ANTARES ULTRASOUND TRANSDUCER

Model Number 5936518

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2016

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 narrative: this supplemental report is being submitted to provide the device available for evaluation; provide the date.New information was received by manufacturer and the type of report.Provide the type of reportable event.The type of follow-up, device evaluated by manufacturer, and update the event problem and evaluation codes; and provide the device evaluation results.The melted power cord/cord retainer was returned to siemens for investigation and the reported phenomenon was confirmed.The cord retainer was the original version used on antares.This cord retainer had already been replaced by a better ul.Approved cord retainer at least 10 years ago.Reference complaint # (b)(4).The original emdr was submitted to the non-production environment.This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 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.It was reported that when the customer service engineer (cse) was on-site at the user facility on another issue, the customer reported the system smelled funny.The cse reloaded the software to isolate the origin of the smell.During that time, the ac power supply smoked and the system shut down.While troubleshooting, the cse followed the odor and found the ac tray and power cord have melted together.The ac tray and the power cord were replaced.The system was not being used to treat or diagnose patient during the reported event.

• Brand Name: ACUSON ANTARES ULTRASOUND TRANSDUCER
• Type of Device: ULTRASOUND TRANSDUCER
• 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: 7828095
• MDR Text Key: 269501554
• Report Number: 3009498591-2016-00357
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063803
• 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
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5936518
• Device Catalogue Number: 5936518
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/11/2016
• 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