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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 No Display/Image (1183); Loss of Power (1475); Self-Activation or Keying (1557)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/02/2018
Event Type  malfunction  
Event Description
Table is shutting off during cases. Customer states generator screen in the console would go offline as if it lost power, could go over to on/off switch and turn on and it would turn right back on. The 2 monitors on the table were also going black, and could not fluoro. Only way to get back on was to reboot the generator. But today, it was working fine. Main issue - the console/generator is spontaneously shut down, no errors in the log. Nothing per ge fse. Fse reseated several connectors, power relay, etc, and it still shut off. Procedure was not completed and patient was moved to ct and finished. No injuries to patient or staff reported.
 
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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
MDR Report Key7549347
MDR Text Key109757314
Report Number1518293-2018-00016
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 05/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2018
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? No
Event Location No Information
Date Manufacturer Received05/02/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/31/2008
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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