MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY-STANDARD

Model Number 404008

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2018

Event Type  malfunction  

Event Description

When in a procedure: they were using the fluoro pedal and they took their foot off the pedal and it would not stop fluoroing.The staff had to hit the emergency stop button.They stated this is not the first time this has happened.No adverse effects on patients and the procedure was completed without further incident.

• Brand Name: HUT EXT DR FINAL ASSY-STANDARD
• Type of Device: HUT 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 Key: 7463846
• MDR Text Key: 106882317
• Report Number: 1518293-2018-00011
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: 404008
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2018
• Date Device Manufactured: 01/31/2006
• Type of Device Usage: N
• Patient Sequence Number: 1