• 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 Z6MS 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 Z6MS ULTRASOUND TRANSDUCER ULTRASOUND DEVICE Back to Search Results
Model Number Z6MS TRANSDUCER
Device Problems Device Displays Incorrect Message (2591); Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/10/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: the complaint was investigated for z6ms probe causes acquisition error 31. The transducer was returned, and an investigation was performed. Engineers were able to reproduce an acquisition 31 error. The cause of the issue was determined to be a gastro flex thermistor trace fault because of gastro flex reliability; this is related to design. Improvements to the gastro flex trace were implemented into forward production, since july 2017. The transducer returned from the customer site was manufactured prior to the corrective action. The transducer was replaced at the site by service. (b)(4).
 
Manufacturer Narrative
The device referenced in this report has not been returned to siemens for evaluation. If additional information is received or if the device is returned at a later date, this report will be supplemented. (b)(4).
 
Event Description
It was reported that during equipment testing and prior to the start of a transesophageal echocardiography (tee) procedure, the transducer generated a usacquisition_hw_31 overtemperature error. The user rebooted the ultrasound system to restore functionality. The planned tee procedure was subsequently performed and completed with a different transducer. There was no patient adverse event reported. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACUSON Z6MS ULTRASOUND TRANSDUCER
Type of DeviceULTRASOUND DEVICE
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
685 east middlefield road
mountain view CA 94043 4050
MDR Report Key7109601
MDR Text Key282187355
Report Number3009498591-2017-00538
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K142628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 03/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberZ6MS TRANSDUCER
Device Catalogue Number10436113
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/22/2018
Is This a Reprocessed and Reused Single-Use Device? No

-
-