MAUDE Adverse Event Report: LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY,RE,FPD

Model Number HUT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2015

Event Type  malfunction  

Event Description

Customer reports via phone that during an undetermined urology procedure, the system fluoro failed.Physician completed the procedure using endoscopy.Customer provided no further patient or procedural information other than to say the patient is fine.No reported injury.

Manufacturer Narrative

Field service engineer (fse) contacted the customer who had called service saying they had a problem with the detector where the infimed system showed a red triangle as the status.This means the infimed could not communicate with the detector.Fse had user re-sync the processor and the infimed by shutting down the infimed and thales processor system and then talked them through the proper start up sequence for the system; processor first then the infimed system.The detector indication on the infimed then came up as normal and they were able to do a fluoro and spot exposure.Unit was fully functional.This issue indicates that the thales processor and the infimed had either gotten out of sync which could happen if there was a power interruption during procedure (or overnight during table shut down), or the unit couldn't re-calibrate itself.Normally the detector requires a black level calibration every 30 minutes.This would be performed in the back ground unless a patient file was open.If a patient file was open in the acquire mode, the system wouldn't perform a black level calibration until the file was closed.After a long period of inactivity with an open patient file, the thales processor shuts off the communication link.It may be that the user didn't check or didn't notice this detector warning on the initial checkout of the system during start up and may have waited until time to fluoro to check.

• Brand Name: HUT EXT DR FINAL ASSY,RE,FPD
• Type of Device: HUT EXT DR
• 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: 4763566
• MDR Text Key: 5795628
• Report Number: 1518293-2015-00038
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/20/2015

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
• Device Catalogue Number: 414007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2015
• Initial Date FDA Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2014
• 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