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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 09/28/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: the complaint was investigated for a temperature problem the the z6ms probe. The transducer was returned, and an investigation was performed. Engineers were able to reproduce an aquisition 31 error. The cause was determined to be articulation sleeve reliability issue. A c-flex articulation sleeve material inspection & rework process was implemented since novevmber 2015. And a new sleeve material change was implemented since septebmer 2016. This transducer was prior to the corrective action. The transducer was replaced at the site. (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 while the patient was in the middle of undergoing a transesophageal echocardiography (tee) procedure, a temperature issue occurred soon after the transducer was connected to the ultrasound system. The physician rebooted the ultrasound system and the functionality was restored. The tee was continued and subsequently completed without replacing the transducer. The delay was only when the system was rebooted. 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 Key6937273
MDR Text Key283390431
Report Number3009498591-2017-00437
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,foreig
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 Received10/10/2017
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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