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

Model Number HUT EXT DR

Device Problems Failure to Power Up (1476); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2014

Event Type  malfunction  

Event Description

Customer reports the system shut off in the middle of a procedure and would not turn on.Staff used a c-arm to complete the procedure.No reported injury.No additional details are known.

Manufacturer Narrative

The mallinckrodt field service engineer (fse) investigated issue and ordered the sedecal console but the g.E.Engineer installed it.The fse called ge and verified it was installed and that the system was functional.The console was the cause of the issue but required obtaining a correct console/flashcard from mallinckrodt for the repair.

• Brand Name: HUT EXT DR FINAL ASSY-STANDARD
• 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: 4135706
• MDR Text Key: 4794032
• Report Number: 1518293-2014-00124
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2014

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
• Initial Date Manufacturer Received: 09/17/2014
• Initial Date FDA Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2008
• 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