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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 ASSY-STANDARD
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/11/2016
Event Type  malfunction  
Manufacturer Narrative
Customer called service reporting that the system was shutting down intermittently and service determined it may be due to the integrated console pn 750772.On a follow up call, the customer said "everything is okay." when asked if unit was operational customer said, "yes".No additional details are available.
 
Event Description
Customer states the generator console shut off in the middle of a case.They were not able to reboot the system.The patient was moved to another room and the procedure was completed without incident.No reported injury.
 
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Brand Name
HUT EXT DR FINAL ASSY-STANDARD
Type of Device
HUT EXT DR FINAL ASSY-STANDARD
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 Key5483543
MDR Text Key40046895
Report Number1518293-2016-00013
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 faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/11/2016
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 ASSY-STANDARD
Device Catalogue Number404008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/11/2016
Initial Date FDA Received03/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2003
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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