MAUDE Adverse Event Report: LIEBEL-FLARSHEIM CO. HUT EXT DR FINAL ASSY - REVERSE

Model Number HUT EXT DR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2014

Event Type  malfunction  

Event Description

Customer reported the system fluoro failed before starting cases for the day.This facility does not have any back up capabilities and the patient procedure was cancelled until the room was repaired.No reported injury.

Manufacturer Narrative

Field service engineer (fse) evaluated the collimator and found that intermittently it would not be able to move one blade.Fse replaced, programmed, and tested te system per service checklist qssri4.1.Unit passed checkout procedures and was returned to the customer for service.

• Brand Name: HUT EXT DR FINAL ASSY - REVERSE
• Manufacturer (Section D): LIEBEL-FLARSHEIM CO.; 2111 east galbraith rd.; cincinnati OH 45237
• Manufacturer Contact: david benson ; 2111 east galbraith rd.; cincinnati, OH 45237 ; 5139485719
• MDR Report Key: 4147902
• MDR Text Key: 19767269
• Report Number: 1518293-2014-00118
• 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
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HUT EXT DR
• Device Catalogue Number: 404007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1