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

Model Number HUT EXT DR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2015

Event Type  malfunction  

Event Description

Customer reports the system failed to fluoro during a patient procedure.Staff was able to complete the unknown procedure with a c-arm.No reported injury.No other patient or procedural details are known.

Manufacturer Narrative

Customer reported that unit would not fluoro or take a digital spot.Field service engineer (fse) investigated for loose connection, checking and re-seating all connections to the atp board.The fse then confirmed the hut dr would take fluoroscopic and digital spot exposures with no problem.Fse then performed system test according to service checklist (b)(4) and returned unit to the customer for service.

Manufacturer Narrative

Field service engineer (fse) due to intermittent failure of the old atp board, replaced the atp board, and performed system test according to service checklist qssrwi4.1.Unit passed checkout procedures and was returned to the customer for service.

• Brand Name: HUT EXT DR FINAL ASSY-STANDARD
• Type of Device: HUT
• 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: 4543603
• MDR Text Key: 15902028
• Report Number: 1518293-2015-00011
• 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: 04/09/2015

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
• Device Catalogue Number: 404008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 02/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2009
• 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