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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 HUT
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/10/2015
Event Type  malfunction  
Event Description
Customer reports that during an unknown procedure the system fluoro was not diagnostic.The patient was moved to another room where the procedure was completed without incident.No reported injury.
 
Manufacturer Narrative
Field service engineer (fse) went on site and determined that the camera needed to be replaced.Fse ordered and replaced the units camera and tested for proper function.Fse checked system per service checklist qssrwi4.1 and returned the unit to the customer for service.
 
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Brand Name
HUT EXT DR FINAL ASSY-STANDARD
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 Key4609856
MDR Text Key20067240
Report Number1518293-2015-00013
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 Biomedical Engineer
Type of Report Initial
Report Date 03/10/2015
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 Number404008
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/10/2015
Initial Date FDA Received03/17/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2010
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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