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

Model Number 404008

Device Problems Leak/Splash (1354); Noise, Audible (3273)

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

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary on (b)(6) 2019, a customer called guerbet service to report that a "strange noise" was coming from their hut urology system, but could not identify which part of the system the noise was coming from.During the call, the customer stated that the system is still fully operational and that no alarms or error codes have been displayed.Several mins later the customer reported that although there was no injury to the patient, a small spot of oil had dripped from the x-ray tube onto a patient during a procedure.On july 25, 2019 guerbet service sent their field service engineer (fse) on-site to examine the system.During the visit, the fse replaced the reported leaking x-ray tube.However, since the replacement tube, serial number (b)(4), could not be calibrated, the fse ordered a replacement x-ray tube, serial number (b)(4), and returned on july 29th to install and calibrate it.After verifying proper operation per service checklist (b)(4), the system was returned to full customer use.Then on (b)(6) 2019, the customer called guerbet service, again reporting that although there was no patient harm, the new x-ray tube had over-heated and leaked small spot of oil onto the patient's blanket during a procedure.Guerbet service issued service ticket (b)(4), complaint (b)(4) to have the system examined.Guerbet's fse revisited the account on august 8, 2019, to investigate the alleged leaking x-ray tube.During this visit the fse confirmed that oil had leaked form the x-ray tube's pressure relief port.Believing the x-ray tube was defective, the fse replaced it with another new tube serial (b)(4).While testing the new tube, the fse noticed a strange noise coming from the x-ray generator, and replaced the generator's digital rotational anode controller (drac) assembly (pn a6378-27).After replacement, the noise remained.With the assistance of l-f and sedecal, the x-ray generator manufacture's technical service support, the problem was isolated to the u17 chip on the drac printed circuit board.The u17 chip was replaced on the original drac board and placed back into the generator.After the system was verified to meet specifications by the completion of the hydravision dr system service checklist (b)(4), the system was returned to full service.Root/probable cause code: equipment/instrument - failure.Root / probable cause summary: equipment/instrument - failure the u17 eprom on the generator's drac board, calculates and monitors the heat units of the x-ray tube based on number of xrays and fluoros executed within a given time period.Additionally, this chip received signals from the tube of its temperature conditions.The malfunction of this component allowed the x-ray tube to slightly over-heat, causing a small amount of cooling fluid (oil) to exit the tubes pressure relief port.Disposition summary: unit returned to service.

Event Description

This incident was reported on (b)(6) 2019, as customer called to report that a "strange noise" was coming from their hut urology system, but could not identify which part of the system the noise was coming from.During the call, the customer stated that the system is still fully operational and that no alarms or error codes have been displayed.Several mins later the customer reported that although there was no injury to the patient, a small spot of oil had dripped from the x-ray tube onto a patient during a procedure.

• Brand Name: HUT EXT DR FINAL ASSY-STANDARD
• Type of Device: HUT EXT DR FINAL ASSY-STANDARD
• 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: 9117893
• MDR Text Key: 220190958
• Report Number: 1518293-2019-00021
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Repair
• Type of Report: Initial
• Report Date: 07/24/2019

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: 404008
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1