MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HVDIS TABLE, REVERSE WITH FPD

Model Number 424007

Device Problem Mechanics Altered (2984)

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

Event Date 06/13/2022

Event Type  malfunction  

Manufacturer Narrative

A complaint was received on hvdis urology table part number 424007 serial number (b)(4).Guerbet tech support spoke to the customer facility's biomed who reported the table wouldn't move and that there was a message that appeared on the tube shroud screen.The error code was not recorded by the operator, and the message could not be recalled.The operator took the patient off the table and made an adjustment to the leg extension position.The table started to move appropriately and without issue.When the patient was back on the table, the table again wouldn't move.Currently, table movement was functioning normally.Tech support advised that a field service engineer (fse) be sent on site to check the table monitor position calibration and to check the leg extension potentiometer for proper operation.The fse went on site, verified that all table movements were functioning normally without any binding.Fse did remove and clean the leg extension sensor as a precaution.The fse verified proper operation according to service checklist qssrwi4.5.The system was fully functional and was returned to customer use.A review of cts shows a table motion halt issue in (b)(6) 2021 where fse investigated and found the a "motion halt" error was due to the leg extension potentiometer getting stuck because of the transducer.Fse replaced the leg transducer pn (b)(4).No injury to the patient/user reported.Imdrf codes: (b)(4) ; (b)(4) ; (b)(4) ; (b)(4).A root cause could not be definitively determined based on the information provided.See overall investigation summary for further details on actions completed.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.Unit remained in service.

Event Description

This incident was reported by a facility in (b)(6) on (b)(6) 2022.The reporter states that they tried to move the table, but the table wouldn't move.There was a message that appeared on the tube shroud screen, but they didn't write it down.They said they took the patient off the table and messed with the leg extension and the table started to work, but when they put the patient back on the table, it wouldn't move again.As of the initial report, the table was moving without issue.The reporter states that the patient was on the table at the time of the incident and was moved to another room, and that there was no injury to patient or staff.

• Brand Name: HVDIS TABLE, REVERSE WITH FPD
• Type of Device: HVDIS TABLE, REVERSE WITH 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: 14976642
• MDR Text Key: 304283636
• Report Number: 1518293-2022-00006
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/13/2022

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: 424007
• Device Lot Number: CI0920H717
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1