• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON 18L6 ULTRASOUND TRANSDUCER ULTRASOUND DEVICE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON 18L6 ULTRASOUND TRANSDUCER ULTRASOUND DEVICE Back to Search Results
Model Number 18L6 TRANSDUCER
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/25/2017
Event Type  malfunction  
Manufacturer Narrative
The device referenced in this report was returned to siemens for evaluation. During investigation, it was found an image artifact and the chips had overheated, confirming the reported complaint. These were due to a coax cable damage noted during the evaluation. The possible root cause of the reported complaint was due to chip damage or electrical short. 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. This report is resubmitted on request by the fda.
 
Event Description
It was reported that the user was performing an ordinary inspection during patient planning when the transducer was noted to be overheating. The user replaced the transducer to continue and complete the unspecified study. There was no need to repeat the study because the reported phenomenon occurred prior to the start of procedure. There was no user or patient injury reported. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACUSON 18L6 ULTRASOUND TRANSDUCER
Type of DeviceULTRASOUND DEVICE
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
685 east middlefield road
mountain view, ca
Manufacturer Contact
christine dunn
22010 se 51st st
issaquah, wa 
7851617
MDR Report Key6525563
MDR Text Key199700485
Report Number3009498591-2017-00063
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K142628
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 02/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number18L6 TRANSDUCER
Device Catalogue Number10789400
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2017
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

-
-