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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC PROTEUS ANALOG XR SYSTEM, X-RAY, STATIONARY

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GE MEDICAL SYSTEMS, LLC PROTEUS ANALOG XR SYSTEM, X-RAY, STATIONARY Back to Search Results
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/26/2019
Event Type  malfunction  
Event Description
The table safety switch had to be replaced on the proteus analog proteus xr ge medical systems.
 
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Brand NamePROTEUS ANALOG XR
Type of DeviceSYSTEM, X-RAY, STATIONARY
Manufacturer (Section D)
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd.
waukesha WI 53188
MDR Report Key9218901
MDR Text Key163172370
Report Number9218901
Device Sequence Number1
Product Code KPR
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 09/24/2019,09/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/24/2019
Event Location Other
Date Report to Manufacturer10/22/2019
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

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