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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INNOVA; SYSTEM, X-RAY, ANGIOGRAPHIC
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GE MEDICAL SYSTEMS INNOVA; SYSTEM, X-RAY, ANGIOGRAPHIC Back to Search Results
Model Number IGS 620
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 12/20/2017
Event Type  malfunction  
Event Description
The table was "free-floating" during the cardiac catheter procedure.The equipment was rebooted but the issue continued.Because the patient was critically ill, the decision was made to proceed with the procedure despite the floating table issue.Manufacturer response for ge cath lab bi-lane imaging table, (per site reporter): part of the problem with the table may be the controller (which doesn't have a number on it) as ge provided us with a "refurbished" controller to use.Ge is aware of the issue and is working on resolving our concern.
 
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Brand Name
INNOVA
Type of Device
SYSTEM, X-RAY, ANGIOGRAPHIC
Manufacturer (Section D)
GE MEDICAL SYSTEMS
eileen fick
3000 n grandview blvd, w-440
waukesha WI 53188
MDR Report Key7158208
MDR Text Key96580630
Report Number7158208
Device Sequence Number1
Product Code IZI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberIGS 620
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/21/2017
Event Location Hospital
Date Report to Manufacturer12/21/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age57 YR
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