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

Model Number 404008

Device Problems Mechanical Problem (1384); Self-Activation or Keying (1557); Failure to Read Input Signal (1581)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019, the biomed at the facility called in and said that the table foot swithc is intermittent, and was given part number because he wanted to order one.He also said that he wanted the fse to check the monitor position calibration.On (b)(6) 2019, the fse verified the reported problem, found longitudinal transducer amplifier pcb was badly corroded, replaced the longitudinal transducer amp pcb.Fse also replaced the i.I.Transducer amp pcb with the upgraded sealant and metal covver.Fse verified operations according to service checklist and reported that the system is fully functional.

Event Description

This incident was reported on (b)(6) 2019, as customer reported that table top is moving without command, also at times it does not move when commanded, and its moving up and down and tilt range is restricted.

• 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 road; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e galbraith road; cincinnati, OH 45237
• MDR Report Key: 8811976
• MDR Text Key: 152074258
• Report Number: 1518293-2019-00015
• 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: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 404008
• Date Manufacturer Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1