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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 Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Computer Operating System Problem (2898)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/03/2018
Event Type  malfunction  
Event Description
Computer cable keeps cutting off and reboots in procedure. During case the computer is freezing up and reboots, this is a platinum one system. Will possibly require a hard drive replacement. Procedure was not completed. No injury reported to patient or staff.
 
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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 Key7475270
MDR Text Key107592900
Report Number1518293-2018-00014
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 05/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2018
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 Received04/03/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/30/2008
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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