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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY,RE,FPD

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LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY,RE,FPD Back to Search Results
Model Number 414007
Device Problems No Display/Image (1183); Image Display Error/Artifact (1304); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/25/2018
Event Type  malfunction  
Event Description
Selected detector is not able to acquire images, stuck in the initializing phase. Message selected detector unable to acquire at this time, all question marks by the detector status, a red triangle where detector status is. Occurred after set up patient on table did not complete procedure. System was stating where the temperature is showing initializing but never went past that. The customer states that the system functioned as intended during their set up of the device. Patient file opened, warm up, test images. The patient was on the table for approximately 1 hour after the test images were taken then they attempted to perform fluoro without success. The system displayed initializing next to the detector status, this did not change. No exposure could be made from the system. Customer called into tech support. I had the customer shutdown the nexus, sedecal, unplug detector power supply, cycle the thales. Once this was complete the system returned to normal operation. It is unknown at this time why this has occurred. Fse required to further investigate and grab logs from nexus.
 
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Brand NameHUT EXT DR FINAL ASSY,RE,FPD
Type of DeviceHUT EXT DR FINAL ASSY,RE,FPD
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 Key7292920
MDR Text Key101122983
Report Number1518293-2018-00003
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121838
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 01/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number414007
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 Received01/25/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/31/2017
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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