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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 Overheating of Device (1437); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/26/2017
Event Type  malfunction  
Manufacturer Narrative
This issue is under investigation. A follow-up report will be submitted when the investigation results are available.
 
Event Description
It was reported that the system displayed a usacquisitionhw_31 error message, an indication that the transducer is overheating. The reported phenomenon occurred during a 3d transesophageal echocardiography (tee) study. Since the system exhibited the error message sporadically, the user was able to complete the tee with the same transducer. There was no loss of data so the study was not repeated. The study was prolonged only by ten minutes but there was no patient or user injury reported. No additional information was provided.
 
Manufacturer Narrative
The device referenced in this report was returned to siemens for evaluation. During visual inspection, there was no physical damage noted on the articulation sleeve area. The device was functionally tested and the temperature monitoring error (usacquisitionhw_31 error) was able to be reproduced. During destructive analysis, it was found an open micro crack on the gastro flex # 7. The possible root cause of the reported phenomenon was caused by electrical trace micro crack due to insufficient reliability. 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. (b)(4).
 
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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 Key6317517
MDR Text Key67153043
Report Number3009498591-2017-00065
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
Type of Report Initial,Followup
Report Date 04/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2017
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2016
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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