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

Model Number 414007

Device Problem No Display/Image (1183)

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

Event Date 09/06/2023

Event Type  malfunction  

Event Description

This incident was reported by a facility in (b)(6) on (b)(6) 2023.The reporter stated that during a bladder tumor dissection, the x-ray system with two monitors, the right monitor picture goes into power saving mode during procedure.The reporter states that they rebooted the system a few times without resolution.The cpu rebooted a few times, lights come on but cpu monitor goes into power saving mode as well, and they are unable to see anything.Reporter also states that prior to the case they lost, the monitor on the right went blank during the case and kept going to a message saying no signal and went into power saving mode.The facility then tried changing inputs, and after this they tried turning the monitor on/off, checked power cables to the monitor.They also rebooted the imaging computer again with a hard shutdown, and after this the nexus would not boot up at all, the reporter is a technologist and stated that the event occurred during a procedure, with the procedure only being partially completed, as the surgeon was unable to complete the portion that required x-ray and that no injury was caused.The patient was connected at the time and no contrast information was provided.

• 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 rd; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e. galbraith rd; cincinnati, OH 45237
• MDR Report Key: 17824733
• MDR Text Key: 324353689
• Report Number: 1518293-2023-00029
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2023

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: 09/06/2023
• Initial Date FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1