MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS ACUSON S2000 6C1 HD TRANSDUCER

Model Number 6C1 HD XDCR

Device Problem Overheating of Device (1437)

Patient Problem Burning Sensation (2146)

Event Date 01/11/2016

Event Type  malfunction  

Manufacturer Narrative

Original submission narrative: the device referenced in this report was returned to siemens for evaluation.The reported event of overheating was not confirmed per the thermal test result.The maximum probe temperature found was 39.1º c at the center area and thermal test result is 40.4ºc, which is below the specification of 50.0ºc.The transducer was functionally tested with an ultrasound system and no system error was able to be reproduced.A review of the device history record (dhr) was performed and there is no information to indicate any non-conformance at the time of manufacturing process.Follow-up narrative: this supplemental report is being submitted to provide additional event information update the patient code ((b)(4), and to provide the date the new information was received by manufacturer.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 on 10/12/16.Additional information was received and it was reported that the procedure was an abdominal exam.There was no need to repeat the procedure as there was no loss of data.There was no patient or user injury reported.No additional information was provided.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 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 while the device was being used, the customer complained that the transducer feels hot on the skin and that the probe head is heating 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: SIEMENS ACUSON S2000 6C1 HD TRANSDUCER
• Type of Device: TRANSDUCER
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; business area ultrasound; 22010 se 51st street; issaquah WA 98029
• MDR Report Key: 6671441
• MDR Text Key: 284880599
• Report Number: 3009498591-2016-00414
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K072786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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: 06/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6C1 HD XDCR
• Device Catalogue Number: 10135941
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2015
• 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