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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 Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/03/2018
Event Type  malfunction  
Manufacturer Narrative
Field service engineer (fse) went on site to investigate customer's report that during a case the system would not allow fluoro. When the fse arrived, he found the system was fully functional. The fse could not duplicate the no fluoro issue as he was able to fluoro and perform digital spot without any problem. Varex review of the logs pulled from the imaging computer found no issue recorded. Fse spoke to the x-ray tech who experienced the issue who said that a "fault alarm reset" message was seen flashing on the generator console during the time that the fluoro had stopped, and that she had shutoff generator console and issue was resolved. When a generator fault alarm occurs on this system, the generator will not allow further exposures until the fault alarm is acknowledged by the operator, either by touching the flashing button that says "fault alarm reset", or as in this case, by the operator who power cycled the generator. Both result in resetting the fault alarm and resetting the generator. After the fault alarm reset, the generator will again allow fluoro / exposures. The operator did not note that alarm was in the `error center' of the generator console when the fault alarm reset button was flashing. It is not known what caused this fault alarm, as it may have been due to an operator error with the foot pedal as surmised by the fse or could have been due to an issue in the generator. System remained in full service. After investigating the system, the fse verified operation according to hut dr service checklist qssrwi4. 1 and returned the unit to full service.
 
Event Description
Incident: lft htdr x-ray/fluoro issues - stopped flouring. During a case the system would not allow fluoro. The x-ray tech who experienced the issue who said that a "fault alarm reset" message was seen flashing on the generator console during the time that the fluoro had stopped, and that she had shutoff generator console and issue was resolved. The operator did not note what alarm was in the `error center' of the generator console when the fault alarm reset button was flashing.
 
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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 road
cincinnati OH 45237
Manufacturer Contact
fred reckelhoff
2111 e galbraith road
cincinnati, OH 45237
MDR Report Key7836761
MDR Text Key119661507
Report Number1518293-2018-00029
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 consumer,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received07/24/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/30/2011
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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