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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 Patient Involvement (2645)
Event Date 08/25/2017
Event Type  malfunction  
Manufacturer Narrative
Not applicable, no adverse event. Lot # and expiration date not applicable. Not applicable, not an implant. Investigation: the complaint was investigated for the z6ms transducer showing an overtemperature error when first connected. The transducer was returned, and an investigation was performed. The error message was reproduced during the investigation. The cause of the issue was determined to be a gastro flex thermistor trace fault, caused by insufficient 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 on 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 that the transducer prompted an over-temperature error when it was connected to the ultrasound system. This occurred prior to a planned transesophageal echocardiography (tee) procedure. The patient was not yet in the room at the time the event occurred; therefore, there was no patient involvement. No additional information was provided.
 
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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
4255571625
MDR Report Key6838461
MDR Text Key247299881
Report Number3009498591-2017-00366
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K142628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 01/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/01/2017
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 Received12/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2016
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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