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: LIEBEL-FLARSHEIM INFIMED, NEXUS IMAGE PROC SYS
  • 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
 

LIEBEL-FLARSHEIM INFIMED, NEXUS IMAGE PROC SYS Back to Search Results
Model Number 710330
Device Problem Computer Software Problem (1112)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2018
Event Type  malfunction  
Event Description
This incident was reported on (b)(6) 2018 as communication error in regards to the software in an lf direct digital imaging system.The reporter stated that the event occurred during a procedure, where the fluoro suddenly stopped working.Reporter states that it was an image acquisition issue and believes it stems from a software problem.The ra/qa manager who is reporting this incident stated that this was a communication error and that the list system monitor was displaying a black screen, and that it occurred during a procedure but there was no harm to the patient.Awaiting investigation results.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INFIMED, NEXUS IMAGE PROC SYS
Type of Device
INFIMED, NEXUS IMAGE PROC SYS
Manufacturer (Section D)
LIEBEL-FLARSHEIM
2111 e galbraith road
cincinnati OH 45237
Manufacturer Contact
fred reckelhoff
2111 e galbraith road
cincinnati, OH 45237
MDR Report Key8214751
MDR Text Key132494639
Report Number1518293-2018-00045
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K121838
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,health p
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number710330
Is the Reporter a Health Professional? No
Date Manufacturer Received12/06/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-