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

Model Number DR FINAL A HUT EXT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2014

Event Type  malfunction  

Event Description

Customer reports via phone that during an kidney stone removal procedure, patient gender and age not reported by the customer, the table movements failed.Staff moved the patient to another room, but they moved the patient back to the urology room, and used the table "over-ride" button to complete the procedure.No reported injury.

Manufacturer Narrative

Field service engineer (fse) investigated and confirmed the table motions complaint, troubleshot and replaced the 24v power supply.After replacing the power supply, fse found that only half of table motions were operable.Further troubleshooting showed failure of the hydraulic pump motor controller.Fse replaced the hydraulic pump motor control assembly and the table operated normally.The unit was checked for proper operation per service manual and returned to full service.

• Brand Name: HUT EXT DR FINAL ASSY - STANDARD
• Manufacturer (Section D): LIEBEL FLARSHEIM; 2111 east galbraith rd.; cincinnati OH 45237
• Manufacturer Contact: david benson, ; 2111 east galbraith road; cincinnati, OH 45237 ; 5139485719
• MDR Report Key: 4102327
• MDR Text Key: 4720588
• Report Number: 1518293-2014-00100
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2014

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: DR FINAL A HUT EXT
• Device Catalogue Number: 404008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/30/2014
• Initial Date FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2003
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1