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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE; IXR
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LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE; IXR Back to Search Results
Catalog Number 404007
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2014
Event Type  malfunction  
Event Description
Customer reports via phone that during an undetermined urology procedure on a male patient, age unknown, the system fluoro monitor failed.Staff moved a portable c-arm fluoro unit into the room, and completed the procedure without further incident.No reported injury.
 
Manufacturer Narrative
Mallinckrodt product monitoring; on a follow up call to the customer was told that biomed had found and replaced a bad monitor power supply, and the system is functioning normally at this time.Customer repair.
 
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Brand Name
HUT EXT DR FINAL ASSY-REVERSE
Type of Device
IXR
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 Key4192555
MDR Text Key16084512
Report Number1518293-2014-00132
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 09/25/2014
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 Catalogue Number404007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/25/2014
Initial Date FDA Received10/22/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/31/2004
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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