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 08/29/2014

Event Type  malfunction  

Event Description

Customer states in the middle of a case the system will not fluoro.The doctor has used digital spot exposures when he needed an image on this procedure.A power cycle on the generator did not fix the problem.No reported injury.

Manufacturer Narrative

Tech service troubleshot a no fluoro issue in the middle of the case when they were trying to use the fluoro footswitch.The doctor was able to use the digital spot exposure when an image was needed.Tech service asked the operator to cycle power to the generator, but the issue remained.Tech service determined the footswitch was the problem.On a follow up call by product monitoring, customer said they had a third party service had come in and rewired the footswitch.The system was fully functional.

• 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: 4147887
• MDR Text Key: 4930700
• Report Number: 1518293-2014-00112
• 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: User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/29/2014

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?: No
• Initial Date Manufacturer Received: 08/29/2014
• Initial Date FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2005
• 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