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 Consequences Or Impact To Patient (2199)

Event Date 01/28/2016

Event Type  malfunction  

Manufacturer Narrative

Field service engineer (fse) investigated and found that the gim drivers had not been properly loaded by someone (not lf service).Fse reloaded and rebooted the gim and then verified proper operation using service checklist (b)(4).The generator interface module can be sensitive to power fluctuations which could have resulted in the gim drivers needing reloaded by customer.

Event Description

Customer reports the system fluoro failed during a patient procedure.Staff was able to complete the procedure without fluoro.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: 5417991
• MDR Text Key: 38294708
• Report Number: 1518293-2016-00011
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/28/2016

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: Nurse
• Device Model Number: HUT EXT DR FINAL ASSY-REVERSE
• Device Catalogue Number: 040007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2009
• 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