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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 404007
Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)
Patient Problem No Information (3190)
Event Date 12/27/2017
Event Type  malfunction  
Event Description
Locks up during scan;error log "system log file full".Customer states cannot proceed even after restart.Customer is stating the system was not able to produce fluoro during the case.This is unknown why but the biomed cody stated the systems were completely shutdown and rebooted which he was unable to reproduce the issue.The customer also indicated the sedecal console displayed a log file is full which made them think there was an issue.This is not an issue that will inhibit the system from functioning.Provided the customer with the procedure to clear the log files.Then requested the customer to attempt to fluoro which he was unable to do.It was then determined this would not occur due to a patient file not being open.They were not in acquire mode.
 
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Brand Name
HUT EXT DR FINAL ASSY-REVERSE
Type of Device
HUT EXT DR FINAL ASSY-REVERSE
Manufacturer (Section D)
LIEBEL-FLARSHEIM
2111 e. galbraith rd
cincinnati OH 45237
Manufacturer Contact
fred reckelhoff
2111 e. galbraith rd
cincinnati, OH 45237
MDR Report Key7198960
MDR Text Key97974152
Report Number1518293-2017-00032
Device Sequence Number1
Product Code IXR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Radiologic Technologist
Type of Report Initial
Report Date 01/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number404007
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/21/2017
Date Device Manufactured01/31/2008
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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