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U.S. Department of Health and Human Services

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

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SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON ANTARES ULTRASOUND TRANSDUCER Back to Search Results
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 This cord retainer had already been replaced by a better ul.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.
 
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Brand NameACUSON ANTARES ULTRASOUND TRANSDUCER
Type of DeviceULTRASOUND 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 Key7828095
MDR Text Key269501554
Report Number3009498591-2016-00357
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 08/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number5936518
Device Catalogue Number5936518
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2016
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

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