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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 Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2018
Event Type  malfunction  
Event Description
Customer reports that device is in error stating monitor collision with table, tilts 20 degrees, and the table thinks the tube head is hitting the monitors but it is not. Table is tilted with feet in the air about 20 degrees. Upon follow-up call, customer stated that he was able to get the table down and tilted the head back up to level by using the collision override button. When this incident originally occured, the patient had to be taken off the table with the table tilted head down and higher than they wanted it. He did not have knowledge, however, if the case was completed. Upon follow-up call on (b)(6) 2018, customer stated that the table is tilted head down, 20 degrees, which is the max head down. When they try and tilt the head end back up, they get the message, monitor collision. Additionally, the table will down move down elevation; only up.
 
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Brand NameHUT EXT DR FINAL ASSY-REVERSE
Type of DeviceHUT EXT DR FINAL ASSY-REVERSE
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 Key7685203
MDR Text Key114543772
Report Number1518293-2018-00022
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 distributor
Reporter Occupation
Type of Report Initial
Report Date 06/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number404007
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/31/2008
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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