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

Model Number 414008

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary: a hospital biomedical engineer contact guerbet technical services stating that a "preparing to expose" message has appeared on the tube shroud display of their dr urology system, but no fluoro exposure occurred.The customer rebooted the system, but received the same results.Guerbet service sent a field service engineer (fse) to the account to investigate this issue.Upon arrival, the fse found that the system was fully operational and functioning normally, therefore, the complaint could not be verified.Prior to leaving, the fse downloaded the system's event logs, and forwarded these to (b)(6), the supplier of the imaging system, for analysis.(b)(6) technical service team analyzed the system's event logs but could not determine the original root cause of the reported issue.(b)(6) did discover that the customer's subsequent attempts to fluoro happened too soon, before the system was ready, or during its detection panel calibration period.The system was designed to inhibit fluoro product during these events.Additionally, (b)(6) noticed that the software for this device was several revisions behind, and recommended a software upgrade be performed.Per (b)(6) recommendations, the fse upgraded the computer's software to mr3 and then mr4, the most current revision.After upgrading the software, the fse verified that the system was performing to specifications by completing the lfddis system service checklist qssrwi4.3.After verifying that the system was fully functional, it was returned to full service.Root/probable cause code: equipment/instrument - failure.Root/probable cause summary: the original root cause remains unknown, however, the upgraded software will provide enhanced communication to the operator alerting them to certain conditions which, by design, will inhibit fluoro production and guide the operator through the recovery process.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 reviews 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 the system is displaying a message saying preparing for exposure when tapping on fluoro but no exposure happened.The ge fse attempted to reset the generator and reset detector communication with negative results.This incident occurred during a procedure where the patient was connected.The procedure was completed, by using ultrasound technology they were able to keep patient on the table, but no fluoro was able to be used, and there was no injury to the patient or staff.

• Brand Name: HUT EXT DR FINAL ASSY,ST,FPD
• Type of Device: HUT EXT DR FINAL ASSY,ST,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: 8699404
• MDR Text Key: 190596475
• Report Number: 1518293-2019-00011
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 414008
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1