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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 EXT DR FINAL A
Device Problems Computer Software Problem (1112); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/12/2014
Event Type  malfunction  
Event Description
Customer reports via phone that during an undetermined urology procedure, the staff reported the computer would not allow them to enter patient information, and fluro failed.Staff moved a portable c-arm fluoro unit into the room, and the procedure was completed without further incident.Customer provided no further patient or procedural information, other than to say the patient is fine.No reported injury.
 
Manufacturer Narrative
The field service engineer (fse) investigated the custome's report that they were unable to get fluoro and that a message on the generator console stated that the park arm was retracted when it was not.Fse verified park arm movement and limits, and re-adjusted the decel (de-acceleration) from 90 to 75 which is the manufacturer recommended setting.Fse reported that he was unable to duplicate the park arm message on generator console unless the park arm was retracted a little (i.E.Not in correct position).Fse also reported that the fluoro was working properly.Customer had also said that they had received a pop up message on the infimed imaging monitor about deleting info and that they were unable to enter patient info.Fse was not able to duplicate this message described by customer.System was working normally.Fse verified system opertion acording to service checklist qssrwi4.1, and returned the unit to the customer for full service.
 
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Brand Name
HUT EXT DR FINAL ASSY-REVERSE
Manufacturer (Section D)
LIEBEL FLARSHEIM
2111 east galbraith rd.
cincinnati OH 45237
Manufacturer Contact
david benson
2111 east galbraith rd.
cincinnati, OH 45237
5139485719
MDR Report Key4095500
MDR Text Key4832393
Report Number1518293-2014-00101
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 User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/12/2014
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 Model NumberHUT EXT DR FINAL A
Device Catalogue Number404007
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/12/2014
Initial Date FDA Received09/08/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2007
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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