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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 EXT DR FINAL ASSY-REVERSE
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/03/2016
Event Type  malfunction  
Manufacturer Narrative
Customer reports that during an unknown procedure, the fluoro froze.Field service engineer (fse) went on site to investigate and was able to resolve the issue by replacing the atp console cpu pcb.Fse verified proper operation according to service checklist qssrwi4.1 and returned the system to the customer for full service.
 
Event Description
Customer reports that during an unknown procedure, the fluoro froze.Staff moved the patient to another room and completed the procedure with a c-arm.No reported injury.
 
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Brand Name
HUT EXT DR FINAL ASSY-REVERSE
Type of Device
HUT EXT DR FINAL ASSY-REVERSE
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 Key5498415
MDR Text Key40563329
Report Number1518293-2016-00022
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 company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/03/2016
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 No Information
Device Model NumberHUT EXT DR FINAL ASSY-REVERSE
Device Catalogue Number404007
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/03/2016
Initial Date FDA Received03/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2001
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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