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

Model Number 404007

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2015

Event Type  malfunction  

Event Description

Customer reports that during a patient procedure the fluoro monitor would black out the image after 2-3 seconds.This site has a control room monitor mounted on the wall and they used it to complete the case.It remained fully functional as well.The procedure was completed without incident no additional details were provided.No reported injury.

Manufacturer Narrative

Tech service directed biomed to look at the viewmax box to ensure either monitor 1 or monitor 2 was set to input 10 for the live fluoro/lih input.Product monitoring followed up with customer on (b)(6) 2015 and was told that the settings on the viewmax had been changed and when they reset monitor one (1) to the correct input all functions resumed.Biomed said the system was fully functional.Customer evaluated and repaired.

• Brand Name: HUT EXT DR FINAL ASSY-REVERSE
• Type of Device: IXR
• 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: 4638235
• MDR Text Key: 5615378
• Report Number: 1518293-2015-00014
• 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 Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/17/2015

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: 404007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2009
• 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