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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE
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LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE Back to Search Results
Model Number HUT
Device Problems Computer Operating System Problem (2898); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2015
Event Type  malfunction  
Event Description
Customer reports that during a cystoscopy the fluoro failed.They were unable to reboot the system and moved the patient to another room to complete the procedure.No reported injury.No additional details are known.
 
Manufacturer Narrative
On a customer follow up, it was determined that the problem was the facilities ups back up battery.Operator was able to plug the system directly into the wall and all functions resumed, but they did not know to try this during their patient procedure.
 
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Brand Name
HUT EXT DR FINAL ASSY-REVERSE
Type of Device
HUT EXT DR
Manufacturer (Section D)
LIEBEL FLARSHEIM
2111 east galbraith road
cincinnati OH 45237
Manufacturer Contact
david benson
2111 east galbraith road
cincinnati, OH 45237
5139485719
MDR Report Key4649956
MDR Text Key19404707
Report Number1518293-2015-00018
Device Sequence Number1
Product Code IXR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Radiologic Technologist
Type of Report Initial
Report Date 03/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHUT
Device Catalogue Number404007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/01/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/28/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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