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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 Problems Difficult To Position (1467); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/09/2018
Event Type  malfunction  
Event Description
Table moves a little bit and then stops. Customer states they have tried foot and hand control and it will not move table. When moving the table top the table is stopping with a message appearing in the message center display stating motion halted. Event occurred during a procedure. Procedure was not completed and had to move patient. No injuries reported to the staff or patient.
 
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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 rd
cincinnati OH 45237
Manufacturer Contact
fred reckelhoff
2111 e. galbraith rd
MDR Report Key7494743
MDR Text Key107847724
Report Number1518293-2018-00013
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 05/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2018
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/09/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/28/2011
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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