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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 EXT DR FINAL A
Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/14/2014
Event Type  malfunction  
Event Description
Customer reports via phone that during an undetermined urology procedure, the system overheated and fluoro failed.Staff moved the patient to another room where the procedure was completed without further incident.No reported injury.Customer did not provide any further patient or procedure information, other than to report the patient is fine.
 
Manufacturer Narrative
Field service engineer (fse) troubleshot system and found that the digital spot settings in the adult mode were at 40 kv, 160 ma, at 2 sec backup time.Fse reset to the default settings of 75 kv, 250 ma, 2 sec backup time; tested the system's heat unit output and found the system functioning normally.This was operator error.Fse inserviced customer on how to reset settings to default.Fse was unable to determine how settings got changed.Fse completed the hydravision dr system service checklist (b)(4) and returned unit to the customer for 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 Key4095511
MDR Text Key4834497
Report Number1518293-2014-00108
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 User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/14/2014
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 NumberHUT EXT DR FINAL A
Device Catalogue Number404008
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/14/2014
Initial Date FDA Received09/08/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2009
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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