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

MAUDE Adverse Event Report: ACFA HEALTHCARE IMPAX AGFA HEALTHCARE; INFORMATION SYSTEM, PICTURE ARCHIVING AND COM

  • 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
 

ACFA HEALTHCARE IMPAX AGFA HEALTHCARE; INFORMATION SYSTEM, PICTURE ARCHIVING AND COM Back to Search Results
Model Number PROLIANT DL320EG8
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/29/2016
Event Type  Injury  
Event Description
A single image in a ct series was flipped and saved.When the radiologist made his final interpretation, there was not a significant visual indication that the image had been manipulated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IMPAX AGFA HEALTHCARE
Type of Device
INFORMATION SYSTEM, PICTURE ARCHIVING AND COM
Manufacturer (Section D)
ACFA HEALTHCARE
112 wade hampton dr
beaufort SC
MDR Report Key6260886
MDR Text Key65313208
Report NumberMW5067302
Device Sequence Number1
Product Code LLZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/13/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPROLIANT DL320EG8
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/13/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age33 YR
Patient Weight69
-
-