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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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GE VINGMED ULTRASOUND AS TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number 6VT-D
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/22/2020
Event Type  malfunction  
Event Description
The tee probe failed the electrical leak test one day, it was not taken out of service, and used on another patient on another day.
 
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Brand NameNA
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
GE VINGMED ULTRASOUND AS
3000 n. grandview blvd
waukesha WI 53188
MDR Report Key10441897
MDR Text Key204007182
Report Number10441897
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6VT-D
Device Catalogue NumberREF # KN100120
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/11/2020
Device Age1 YR
Event Location No Information
Date Report to Manufacturer08/24/2020
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?
Type of Device Usage

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