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

Model Number 414007

Device Problem Failure to Power Up (1476)

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

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary: customer called guerbet service reporting that their hydravision urology system was unable to produce fluoro during a case.The customer stated that they tried cycling the power on the computer, generator and the table, but were still not able to produce fluoro.Guerbet service suggested transferring the call to guerbet's technical support so that immediate assistance could be provided.However, the customer declined, asking that a field service engineer(fse) be dispatched to check the system.The customer then moved the patient to another table and completed the case using portable fluoroscopy.Guerbet's the fse went on site to confirm the complaint.In addition to power-cycling the computer, generator and table, he also power-cycled the thales imaging processor and detector, after which the system booted up normally and was able to produce fluoro.The fse then verified proper operation using service checklist qssrwi4.3 and returned the system to full service.A review of cts shows no similar issues reported on this unit.Root/probable cause code: equipment/instrument - software.Root / probable cause summary: the thales imaging processor required a reboot.No further investigation needed at this time.Qa will continue to monitor and trend for similar issues.No capa at this time, these trends and issues are reported on during quality metrics review and during the management review meetings to consider input for corrective action.Disposition summary: unit remained in full service.

Event Description

This incident was reported on (b)(6) 2019, as customer called guerbet service reporting that their hydravision urology system was unable to produce fluoro during a case.The customer stated that they tried cycling the power on the computer, generator and the table, but were still not able to produce fluoro.

• Brand Name: HUT EXT DR FINAL ASSY,RE,FPD
• Type of Device: HUT EXT DR FINAL ASSY,RE,FPD
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e galbraith road; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e galbraith road; cincinnati, OH 45237
• MDR Report Key: 9196614
• MDR Text Key: 193974879
• Report Number: 1518293-2019-00022
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/17/2019

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: 414007
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1