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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); Loss of Data (2903); Device Operational Issue (2914)
Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)
Event Date 03/11/2018
Event Type  malfunction  
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. (b)(4).
 
Event Description
It was reported that the z6ms transducer was generating an over-temperature shutdown when used with the sc2000 ultrasound system. The doctor was performing a tee procedure with the tube inside the patient , while the patient was under sedation. The event occurred at the beginning of the procedure. The system was rebooted, and the procedure completed with the same ultrasound system. Completion of the procedure was delayed by 6 minutes. Additional sedation was administered to the patient as a result of the delay. There was no patient injury as a result. No additional information was provided.
 
Manufacturer Narrative
This supplemental report is being submitted to provide patient information. (b)(4).
 
Event Description
The transducer was replaced and because there was loss of data, the transesophageal echocardiography (tee) exam was repeated.
 
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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
Manufacturer Contact
scott christiansen
685 east middlefield road
mountain view, CA 94043
4252709862
MDR Report Key7419766
MDR Text Key105440976
Report Number3009498591-2018-00012
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberZ6MS TRANSDUCER
Device Catalogue Number10436113
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/23/2018
Was Device Evaluated by Manufacturer? Yes
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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