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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGFA N.V. DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100; DX-D 100 MOBILE
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AGFA N.V. DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100; DX-D 100 MOBILE Back to Search Results
Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Agfa received a notification from fda of medwatch report # (b)(4) in which a customer in the us reported "the system has encountered an unexpected error.When you click ok, you can continue working, but data integrity is no longer guaranteed." investigation is underway and a supplemental report will be provided.
 
Event Description
This supplement report #1 is being submitted to provide the root cause and actions taken.See h10 for additional information.
 
Manufacturer Narrative
Investigation by agfa confirmed the log files from the reported incident (november 2019) are no longer available, and no further investigation can be done.Based on the information reported via medwatch report # (b)(4), a corrupt image was possibly the result of a communication/calibration issue.This is an isolated case of a image retake which according to agfa's risk policy is in the broadly acceptable range.Based on this, there are no future actions for this event.There has been no reported harm to patient or users for this event.
 
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Brand Name
DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100
Type of Device
DX-D 100 MOBILE
Manufacturer (Section D)
AGFA N.V.
septestraat 27
mortsel, B2640
BE  B2640
MDR Report Key10045068
MDR Text Key190907053
Report Number3001556265-2020-00003
Device Sequence Number1
Product Code IZL
Combination Product (y/n)N
PMA/PMN Number
K103597
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 05/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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