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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 404008
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); No Display/Image (1183); Failure to Power Up (1476); Device Stops Intermittently (1599); Computer Operating System Problem (2898); Failure to Shut Off (2939)
Patient Problem No Information (3190)
Event Date 05/19/2017
Event Type  malfunction  
Event Description
Sedecal integrated console display out. Patient was on the table and the sedecal integrated console went blank. Reboots of the console would not bring up the screen. Patient had to be moved to another room. There was a "foob" for the console. Intermittently generator console (old style) freezes and will not reboot. New console will not power on/off generator. The first replacement console was reported as a failure out of box and returned to lf for evaluation on rga 57221811. Evaluation of this console was done by r and d ((b)(6)) who found that the console would power on but not turn on the generator. Further investigation found cause was a broken c1 capacitor on the `turn on' pcb located at the bottom of the console enclosure. The console was returned to sedecal for repair.
 
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Brand NameHUT EXT DR FINAL ASSY-STANDARD
Type of DeviceHUT EXT DR FINAL ASSY-STANDARD
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 Key6646695
MDR Text Key77940665
Report Number1518293-2017-00017
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 06/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number404008
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/31/2012
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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