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

Model Number DR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2014

Event Type  malfunction  

Event Description

Customer reports at the end of a cysto procedure, the physician decided to use fluoro and the generator console touchscreen was locked and the fluro would not work.The procedure was completed and the patient was sent to the radiology department for a final film.No additional patient details are available.No reported injury.

Manufacturer Narrative

Pending investigation.Upon receipt of investigation, a medwatch 3500a supplemental report will be submitted.

Manufacturer Narrative

Field service engineer (fse) confirmed the console lockup but could reboot system and console would operate ok.Customer said this issue has been intermittent for a time.Fse checked connections and functions and was able to duplicate one time and decided to replace the console.Fse completed check of system per service checklist qssrwi4.1 and returned unit to the customer for full service.The failed console was returned to (b)(4) for evaluation.(b)(4) reported that the cooling fans had failed causing the unit to overheat, giving the intermittent failure.

• 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 ; 5139495719
• MDR Report Key: 4147895
• MDR Text Key: 4913995
• Report Number: 1518293-2014-00113
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/27/2015

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: DR
• Device Catalogue Number: 404007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2014
• Initial Date FDA Received: 09/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2007
• 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