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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY,RE,FPD; MQB
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LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY,RE,FPD; MQB Back to Search Results
Model Number 414007
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2015
Event Type  malfunction  
Event Description
Customer reports via phone that during an undetermined urology procedure, the fluoro failed.Physician completed the procedure using rad images.Customer provided no further patient or procedural information other than to say the patient is fine.No reported injury.
 
Manufacturer Narrative
Field service engineer (fse) investigated customers report that they couldn't take fluoro images with the footswitch without rebooting the generator.Fse troubleshot and replaced the generator atp console board to resolve the issue.While on site fse upgraded generator console software from v2.28 to v2.28.1 and performed the required 90-day detector gain calibration for ddis systems.Fse verified proper operation per ddis system service checklist and returned unit to full service.
 
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Brand Name
HUT EXT DR FINAL ASSY,RE,FPD
Type of Device
MQB
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 Key4838839
MDR Text Key5914839
Report Number1518293-2015-00050
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121838
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 05/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number414007
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/13/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2014
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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