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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS ACUSON ANTARES CH5-2 TRANSDUCER ULTRASOUND DEVICE

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SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS ACUSON ANTARES CH5-2 TRANSDUCER ULTRASOUND DEVICE Back to Search Results
Model Number CH5-2 TRANSDUCER
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problems Shock (2072); Electric Shock (2554)
Event Date 04/06/2017
Event Type  Injury  
Manufacturer Narrative
Investigation: the device referenced in this report was returned to siemens for investigation. This complaint was investigated for the event where the patient and user felt electric shocks while using ch6-2 transducer. The initial report was submitted on model# ch6-2 transducer, with serial number (b)(4), but engineering confirmed that this serial number is for a ch5-2 transducer. Thus, this information in being corrected in the report. The defective transducer was not returned as a complaint part and therefore, was scrapped without engineering evaluation. Thus, an investigation for root cause determination of the issue could not be performed. 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. Complaint reference #: (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 the reported that a female patient who is pregnant and the usual user of the device at the user facility underwent an obstetric scan performed by another doctor. During the procedure, the patient and the doctor started to feel electrical shocks that was reported to generate from the transducer; however, the procedure was completed with no equipment changes. There was no loss of data so the scan was not repeated. No additional information was provided.
 
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Brand NameSIEMENS ACUSON ANTARES CH5-2 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 Key6525747
MDR Text Key185835036
Report Number3009498591-2017-00175
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K063803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCH5-2 TRANSDUCER
Device Catalogue Number08648086
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/25/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/13/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/27/2017 Patient Sequence Number: 1
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