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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO.,LTD. VIVID IQ TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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GE MEDICAL SYSTEMS (CHINA) CO.,LTD. VIVID IQ TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number VIVID IQ R1R2 TO R3 UPG
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 11/04/2021
Event Type  malfunction  
Event Description
Ice machine (vivid iq) not working when needed at the started of a procedure. After calling several people to trouble shoot, the machine had a work order placed. There were no other machines available.
 
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Brand NameVIVID IQ
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
GE MEDICAL SYSTEMS (CHINA) CO.,LTD.
3000 n. grandview blvd
waukesha WI 53188
MDR Report Key12827697
MDR Text Key280885707
Report Number12827697
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
Report Date 11/08/2021,11/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberVIVID IQ R1R2 TO R3 UPG
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/08/2021
Event Location Hospital
Date Report to Manufacturer11/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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