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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: X-RAY MACHINE

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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.
 
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Type of DeviceX-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
0 Patients were 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
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
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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