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

Model Number HUT EXT DR FINAL ASSY-REVERSE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) evaluated the system and found intermittent power problems with the touchscreen console.He resolved this by replacing the generator console.Fse checked the unit for proper operation using service manuals 4041004, 710953, 710951, 710273.Unit passed checkout procedures and was returned to the customer for service.

Event Description

Customer reported the console failed during a patient procedure.Staff was able to move the patient to another room where they completed the procedure without incident.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: 5496155
• MDR Text Key: 40432382
• Report Number: 1518293-2016-00020
• 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: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/29/2016

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2016
• Initial Date FDA Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2010
• 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