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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
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/18/2015
Event Type  malfunction  
Event Description
Customer reports the monitors failed during a cystogram procedure.Staff was able to complete the procedure by taking x-ray shots.No patient injury.
 
Manufacturer Narrative
Customer called service reporting the table monitors were not working.Field service engineer (fse) then called the customer and told the biomed to check the monitor power supply.The biomed stated the monitor power supply was not working.Fse advised replacing the power supply , and biomed stated he would order and replace the failed power supply, (b)(4).On a follow up with customer, it was confirmed that the power supply had been replaced and the system was fully functional.Biomed repaired system.
 
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Brand Name
HUT EXT DR FINAL ASSY-REVERSE
Type of Device
HUT EXT DR F
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 Key4571790
MDR Text Key5458489
Report Number1518293-2015-00012
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 02/18/2015
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 Number404007
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/18/2015
Initial Date FDA Received03/05/2015
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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