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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC PRECISION 600; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE

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GE MEDICAL SYSTEMS, LLC PRECISION 600; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE Back to Search Results
Device Problems No Display/Image (1183); Data Back-Up Problem (2902)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2019
Event Type  malfunction  
Event Description
Pt was undergoing fluoroscopy imaging when the tech was not able to take an image or save the last image.Handle on fluoro system replaced.Fda safety report id# (b)(4).
 
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Brand Name
PRECISION 600
Type of Device
SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE
Manufacturer (Section D)
GE MEDICAL SYSTEMS, LLC
MDR Report Key9348257
MDR Text Key167320064
Report NumberMW5091178
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/18/2019
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 Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/19/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age30 YR
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