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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
Model Number 404007
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/16/2015
Event Type  malfunction  
Event Description
Customer reports via phone that staff were attempting to start room for procedures when the computer failed.Customer does not have a back up room, all procedures were cancelled.No reported injury.
 
Manufacturer Narrative
Field service engineer (fse) troubleshot system and found hard drive on the computer was not booting up.Fse replaced the hard drive , configured and verified proper operation per hydravision dr service checklist.Unit passed checkout procedures and was returned to full service.
 
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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 Key4748760
MDR Text Key5889151
Report Number1518293-2015-00037
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 Nurse
Type of Report Initial
Report Date 04/16/2015
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 Number404007
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/16/2015
Initial Date FDA Received05/05/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2005
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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