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U.S. Department of Health and Human Services

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

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SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS ACUSON S2000 6C1 HD TRANSDUCER Back to Search Results
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.
 
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Brand NameSIEMENS ACUSON S2000 6C1 HD TRANSDUCER
Type of DeviceTRANSDUCER
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
business area ultrasound
22010 se 51st street
issaquah WA 98029
MDR Report Key6671441
MDR Text Key284880599
Report Number3009498591-2016-00414
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K072786
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received06/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6C1 HD XDCR
Device Catalogue Number10135941
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2016
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2015
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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