• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE PROTEUS XR X-RAY MACHINE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GE HEALTHCARE PROTEUS XR X-RAY MACHINE Back to Search Results
Model Number 531995
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/19/2016
Event Type  malfunction  
Event Description
Vertical bucky has exposure hold that will not allow the room to expose for lateral chests or lateral c-spines.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROTEUS XR
Type of DeviceX-RAY MACHINE
Manufacturer (Section D)
GE HEALTHCARE
waukesha WI
MDR Report Key6232422
MDR Text Key64343710
Report NumberMW5067089
Device Sequence Number1
Product Code KPR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number531995
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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

-
-