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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. EC9-4 TRANSDUCER TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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SIEMENS MEDICAL SOLUTIONS USA, INC. EC9-4 TRANSDUCER TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number 10041225
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/23/2017
Event Type  malfunction  
Event Description
The probe was given to the biomed department to repair cracked housing on the connector side.
 
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Brand NameEC9-4 TRANSDUCER
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
22010 s.e. 51st st.
issaquah WA 98029
MDR Report Key6878613
MDR Text Key86751509
Report Number6878613
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/23/2017,08/28/2017
1 Device was Involved in the Event
1 Patient was 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 Number10041225
Device Lot NumberC4553580
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/23/2017
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer08/23/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/20/2017 Patient Sequence Number: 1
Treatment
N.A.
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