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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON Z6MS ULTRASOUND TRANSDUCER ULTRASOUND DEVICE

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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 Information (3190)
Event Date 10/16/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: the complaint was investigated for the z6ms transducer getting a temperature monitoring error when connected. 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 reliability issue; 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. Complaint reference #: (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.
 
Event Description
It was reported by the customer that as soon as the transducer was connected to the ultrasound system, it prompted an unknown acquisition error and temperature error messages. No additional information was provided. Multiple attempts were made via email and telephone to obtain additional information regarding the reported phenomenon and patient outcome but with no results.
 
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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
Manufacturer Contact
scott christiansen
685 east middlefield road
mountain view, CA 94043-4050
4252709862
MDR Report Key7025600
MDR Text Key195843566
Report Number3009498591-2017-00476
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Biomedical Engineer
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 02/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2017
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/06/2017
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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