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

Model Number HUT EXT DR FINAL ASSY-REVERSE

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

Tech support troubleshot with the biomed and advised him on steps to try to assess the cause of the problem.Tech service had biomed tried replacing parts but this did not resolve the problem.On a follow up call, biomed reported the system had been repaired.The problem was the operators had originally crashed the tube shroud into a step stool.They used the override to keep moving the table and did not report this until after several crashes occurred.Biomed was able to clear the errors and get the system working as the engineers intended once it was reported to him.

Event Description

Customer reports during an unknown patient procedure, the imaging chain is at the head end and will not move down to the foot.This caused the table tilt movement to be stopped and although fluoro worked, it was positioned over the patient's head and not useful to the physician.Staff was able to complete the procedure without using x-ray.No reported injury.

• Brand Name: HUT EXT DR FINAL ASSY-REVERSE
• Type of Device: HUT EXT DR FINAL ASSY-REVERSE
• Manufacturer (Section D): LIEBEL FLARSHEIM; 2111 east galbraith road; cincinnati OH 45237
• Manufacturer Contact: david benson ; 2111 east galbraith road; cincinnati, OH 45237 ; 5139485719
• MDR Report Key: 5150506
• MDR Text Key: 28650984
• Report Number: 1518293-2015-00102
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Report Date: 09/22/2015

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 FINAL ASSY-REVERSE
• Device Catalogue Number: 404007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1