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

Model Number 404008

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary: a customer contacted guerbet technical services stating that after placing a patient on the table, their hydravision dr urology system intermittently displays "image intensifier splash/crash error" or "monitor arm pot a or pot b error".Since the customer could not clear these messages, they used a c-arm to complete the procedure.Guerbet technical services sent their field service engineer (fse) to investigate the issue.The complaint was confirmed, the fse explained that the "image intensifier splash/crash error" message is a collision avoidance safety feature of the device.It indicates that something may have collided with the housing that protects the image intensifier, the device that collects the xray/ fluoro images.Although this error message will not inhibit x-ray or fluoro production, it will prevent the table from being lowered any further to prevent damage to the image intensifier.Likewise, the "monitor arm pot a or pot b error" is also a collision avoidance safety feature to prevent the table from colliding with the systems display monitors.Although this error message will inhibit certain table movements, it will not prevent x-ray or fluoro production.During his investigation, the fse discovered the that "image intensifier splash/crash error" message was caused by two loose screws on the splash/crash sensor.The fse returned the sensor to its proper position and retightened the screws.Additionally, the fse found that the monitor position sensor needed to be recalibrated to eliminate the "monitor arm pot a or pot b error".After these adjustments, the fse verified proper operation according to hydravision dr system service checklist qssrwi4.1.The system was fully functional and returned to service.A review of guerbet complaint tracking system showed no related complaint activity for this device.Root / probable cause code: equipment/instrument - failure, root / probable cause summary.Refer to investigation summary.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 service.

Event Description

This incident was reported by a facility in (b)(6) on (b)(6) 2021.The customer complained that their hydravision dr urology system intermittently displays "image intensifier splash/crash error" or "monitor arm pot a or pot b error".Since the customer could not clear these messages, they used a c-arm to complete the procedure.Customer states that there was a patient attached at the time, but there was not injury to patient or staff.

• 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 rd; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e. galbraith rd; cincinnati, OH 45237
• MDR Report Key: 11293951
• MDR Text Key: 232553767
• Report Number: 1518293-2021-00003
• 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: distributor,health profession
• Reporter Occupation: 505
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/11/2021

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
• Device Lot Number: CI0907H285
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 02/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2007
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1