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 Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2014

Event Type  malfunction  

Event Description

Customer reports by phone fluoro failed during a patient procedure.The procedure was completed by moving the patient to another room.No additional patient or procedural details are known.No reported injury.

Manufacturer Narrative

Tech service initially troubleshot with biomed and had sent him an atp pcb to correct the reported no fluoro issue.When biomed called back and reported same problem after trying the afp board, a field service engineer (fse) was sent on site.Fse found the problem was due to replacement due to cost and the fact that they were looking to replace this system.Table can only be used in limited service as there is no fluoro.Service ticket was closed.

Manufacturer Narrative

(b)(4): customer called liebel flarsheim, saying they decided to repair, but then elected to do an i5 computer system upgrade.This was completed in october.Unit was tested and checked for proper operation and returned to full service.A review shows no similar generator interface module issue reported on this unit.

• 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: 4147889
• MDR Text Key: 15362217
• Report Number: 1518293-2014-00115
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2014

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?: No
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 09/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2007
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1