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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 Problem Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/18/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: the complaint was investigated for the z6ms transducer having a thermal warning. 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. (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 after the patient was sedated, the patient underwent a standard 3d transesophageal echocardiography (tee) procedure. As the physician was getting ready to start the procedure, the transducer generated a temperature warning. The transducer would be okay for about a minute and then gave the temperature warning again. This occurred on multiple occasions when the physician reconnected and tried all the ports and got the same result. The transducer was removed and a new transducer was reinserted into the patient. The procedure was delayed by 20 minutes but it was successfully completed. There was no loss of data and there was no patient adverse event reported. 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
MDR Report Key6984617
MDR Text Key283399815
Report Number3009498591-2017-00467
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,health
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2017
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 Received01/08/2018
Is This a Reprocessed and Reused Single-Use Device? No

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