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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 03/13/2017
Event Type  malfunction  
Manufacturer Narrative
This supplemental report is being submitted to update the device available for evaluation, provide the date received by manufacturer, update device evaluated by manufacturer, provide the device manufacture date, update the event problem and evaluation codes, and provide the device investigational results. The device referenced in this report was returned for evaluation. Engineering investigated the issue and found that there was no visible damage at articulation sleeve area. The system error 31 was reproduced during system test. The inter-connectivity test failed at thermistor net. Through destructive analysis, it was found a thermistor+ traces crack and open on gastro flex #7 soldering area which could lead to system error 31 (temperature/thermal). Electrical open was confirmed by multimeter test. The possible root cause was determined as gastro flex thermistor trace crack and open because of insufficient cable assembly and/or gastro flex reliability which is related to design. 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.
 
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 patient was already sedated and on the table undergoing an open heart surgery. In the middle of the procedure, the transducer prompted an over-temperature monitor error. The health professional replaced the transducer and completed the surgery using the same ultrasound system. There was a short delay while the replacement transducer was obtained. 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
Manufacturer Contact
scott christiansen
685 east middlefield road
mountain view, CA 94043-4050
4255571625
MDR Report Key6458221
MDR Text Key161311730
Report Number3009498591-2017-00151
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
Type of Report Initial,Followup
Report Date 07/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2017
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?
Event Location No Information
Date Manufacturer Received07/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/21/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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