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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-STANDARD
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LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-STANDARD Back to Search Results
Model Number DR FINAL A HUT EXT
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/06/2014
Event Type  malfunction  
Event Description
Customer reports via phone that during a retrograde cystogram on a female patient (age unk), the system fluoro failed.Physician completed the procedure using endoscopy.No reported injury.Customer does have a back up room.
 
Manufacturer Narrative
Field service engineer (fse) went on site, troubleshot the imaging chain and found the transducer board on the image intensifier causing the problem.Fse replaced the transducer board and checked the system for proper operation per hydradjust dr service manual and service checklist.Fse returned the unit to full service.
 
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Brand Name
HUT EXT DR FINAL ASSY-STANDARD
Manufacturer (Section D)
LIEBEL FLARSHEIM
2111 east galbraith rd.
cincinnati OH 45237
Manufacturer Contact
david benson,
2111 east galbraith rd.
cincinnati, OH 45237
5139485719
MDR Report Key4102311
MDR Text Key15120317
Report Number1518293-2014-00097
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,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/06/2014
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 NumberDR FINAL A HUT EXT
Device Catalogue Number404008
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/06/2014
Initial Date FDA Received08/27/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2011
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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