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

Model Number 414008

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary impact assessment summary a hospital biomed contact guerbet service to report that with a (b)(6) lbs.Patient on the table, their hut dr urology system's table started to move in a trendelenburg position without being commanded by the user.There was no harm to the patient as the patient was removed from the table by the hospital staff.Guerbet technical services followed-up with a phone call to the biomed, then sent their field service engineer (fse) on-site to investigate this complaint.The fse reported that upon arrival, the table was in the horizonal position.The fse tested the table, but could not duplicate the issue.During the investigation, the fse did noticed that when traversing the table from the trendelenburg position, a directional error occurred.The system identified that the table was in the horizonal position, when in fact it was not.The fse then reseated the longitudinal transducer amp pc board and retested the system.No further errors occurred.Therefore, the fse verified proper system operation according the lfddis system service checklist qssrwi4.3.As the system proved fully functional, it was returned to full service.A review of cts shows no similar issue previously reported on this unit.Root / probable cause code: unknown.Root / probable cause summary: unknown.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 returned to service.

Event Description

Initial information was received on 18 february 2020, as reporter states that a (b)(6)-lb.Patient was on the table, and the table started moving trendelenburg without a command from th user.The reporter states that the patient did not fall off the table.The reporter believes that they or staff took the patient off the table at this point.This event was reported to occur during a procedure and reporter states that the procedure was completed without any injury to patient or staff.

• Brand Name: HUT EXT DR FINAL ASSY,ST,FPD
• Type of Device: HUT EXT DR FINAL ASSY,ST,FPD
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e galbraith road; cincinnati, oh
• Manufacturer Contact: fred reckelhoff ; 2111 e galbraith road; cincinnati, oh
• MDR Report Key: 9848956
• MDR Text Key: 207756772
• Report Number: 1518293-2020-00005
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 414008
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1