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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 Consequences Or Impact To Patient (2199)
Event Date 09/10/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: the complaint was investigated for the z6ms transducer having a temp 31 error message. The transducer was returned, and an investigation was performed. The system error was reproduced during the investigation. The cause of the issue was determined to be a gastro flex thermistor reliabiility issue; this is related to design. The improvements to the gastro flex trace were implemented into forward production, since july 2017. The returned transducer 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 a patient was put under sedation to undergo a heart exam. Although the exact timeline of the failure was not reported, there was an indication that the exam was in progress when the transducer prompted a temperature error. The error occurred when the transducer was connected to the ultrasound system. The doctor removed the transducer from the patient and reinserted a new transducer to continue and successfully complete the exam. It is unknown whether the ultrasound system was rebooted. There was a delay of approximately 15 minutes while the new transducer was prepared. 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 Key6878949
MDR Text Key282198245
Report Number3009498591-2017-00385
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 01/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2017
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 Received01/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

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