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

Model Number 414007

Device Problem Unintended System Motion (1430)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary a complaint was received on hut dr urology suite 414007 serial number (b)(6) where the customer alleged that they thought the table was continuously overexposing the patient with fluoro and that the foot pedal was in poor condition.A service engineer was dispatched to the customer site to check the system and reported that he was not able to reproduce the reported problem but did find the condition of foot pedal was poor as some components were corroded from spilled fluid or from cleaners being used.Service engineer looked at audit logs for the times when the user alleged the issue was occurring.The service engineer reported that everything looked acceptable and that there were no cases that looked to have anything abnormal.During this inspection, service engineer noted that the system's uninterruptable power system (ups) started to alarm, with a sound similar as if the system was producing fluoro.This sound lasted for about 30-45 seconds.The service engineer took a video which included sound and showed it to one of the nurses, who confirmed that it was the noise that they were hearing when they thought the system was making fluoro.Service engineer suspects that the ups alarm was the issue and not continued fluoro and overexposure as thought by some staff.Service engineer replaced the worn footswitch and sent a replacement ups to the site.The system was tested for proper operation and returned to customer use.A review of cts shows no similar issue reported on this unit.Impact assessment summary no injury to the patient/user reported imdrf codes: b01; c19; d14.Root/probable cause code personnel - training - inadequate root/ probable cause summary refer to investigation summary.As service found nothing wrong with the device during investigation, no corrective action was possible.Although no additional capa is required at this time, guerbet quality will continue to monitor and trend for similar issues.These trends and issues are reported on during quality metrics review and during the management review meetings to consider input for additional corrective action.Disposition summary unit returned to service.

Event Description

This incident was reported by a facility in kentville, nova scotia, canada on date (b)(6) 2023 for an event that occured on (b)(6) 2023.Facility states that system was still beeping after urologist had let his foot off the pedal.X ray tech was called and when he arrived could see that the radiation symbol was lit, system was beeping like it was making fluoro and fluoro counter was counting.He could see motion on the image.He could see motion on the image also.He immediately shut off the generator to stop xray and then did a quick investigation.He also noted he thought the foot switch may have been stuck or inadvertently held.Dr in the or mentioned he think this may have happened recently on another occurrence but it was not reported.Upon restarting the system no xray was being produced.

• Brand Name: HUT EXT DR FINAL ASSY,RE,FPD
• Type of Device: HUT EXT DR FINAL ASSY,RE,FPD
• Manufacturer (Section D): LIEBEL- FLARSHEIM; 2111e. galbraith rd; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e. gralbraith rd; cincinnati, OH 45237
• MDR Report Key: 17483990
• MDR Text Key: 321541881
• Report Number: 1518293-2023-00019
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/25/2023

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: 07/25/2023
• Initial Date FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1