Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; 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
 

; X-RAY MACHINE Back to Search Results
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/28/2017
Event Type  malfunction  
Event Description
Was doing a chest x-ray and exposed for the first view.Machine exposed, but the image did not appear.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
X-RAY MACHINE
MDR Report Key6672911
MDR Text Key78575627
Report Number6672911
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/19/2017
Event Location Hospital
Date Report to Manufacturer06/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
-
-