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

Model Number HUT EXT DR FINAL ASSY-STANDARD

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

Field service engineer (fse) investigated customer's report of low memory and blank screen after a reboot.The fse reseated (b)(4) console flash card.After this the error message was gone, but the touchscreen was not responding correctly on the console.Fse reloaded the touch screen driver and the console returned to normal.Fse checked for proper operation according to service checklist qssrwi4.1 and returned the unit to the customer for full service.

Event Description

Customer reports the system failed during an unknown procedure.Staff brought in a c-arm and completed the case without incident.No reported injury.

• Brand Name: HUT EXT DR FINAL ASSY-STANDARD
• Type of Device: HUT EXT DR FINAL ASSY-STANDARD
• 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: 5498683
• MDR Text Key: 40562861
• Report Number: 1518293-2016-00019
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2016

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-STANDARD
• Device Catalogue Number: 404008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2007
• 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