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

Model Number 404008

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary customer reported that during a case the table started tilting reverse trendelenburg, head up, un-commanded.They immediately removed the patient.There were no injuries.A field service engineer (fse) went on site and confirmed the tilt pedal was intermittently sticking.The fse took the foot switch assembly apart, cleaned and serviced the pedal.The foot pedal was then tested and functioned normally.The fse verified proper operation per the table portion of the hydravision dr system service checklist qssrwi4.1 and returned the table to customer use.A review of cts shows this table movement footswitch had been replaced in (b)(6) 2019 when fse broke retaining screws during cleaning a sticking pedal.Impact assessment summary.No patient injury.Imdrf codes: (b)(4).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 returned to customer use.

Event Description

This incident was reported by a facility in (b)(6) on 15 (b)(6) 2021.The customer reported that during a case, the table started tilting head up, uncommanded, and they had to immediately remove the patient.The reporter stated that the event happened during a procedure, and that the procedure was completed with no reported 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
• MDR Report Key: 12614505
• MDR Text Key: 277673057
• Report Number: 1518293-2021-00029
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• 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: CI0913H623
• Date Manufacturer Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1