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

Model Number HUT EXT DR FINAL A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2014

Event Type  malfunction  

Event Description

Customer reports via phone that staff had started a retrograde cystogram on a patient, when the table movement failed.Customer reports staff were removing the leg extension, and were experiencing difficulty in removal of the leg extension.After the leg extension was removed, the table movement function failed, and staff had to move the patient to another room to complete the procedure.Customer reports the procedure was completed, but provided no additional information on patient, other than to say the patient is fine.No reported injury.

Manufacturer Narrative

Field service engineer (fse) investigated and found when the table was tilted, it would display an error on the screen which said 'the a pot in the monitor arm failed'.Fse also found that the leg extension sensor was out of the table and the wires were pulled out of the connector with the connector still in the board.Fse replaced the sensor and re-assembled the leg extension sensor assembly and checked the sensor for proper operation.This repaired the leg extension sensor and also resolved the monitor arm sensor issue.Fse tested the system per service checklist (b)(4).Unit passed checkout procedures and was returned to the customer for 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 rd.; cincinnati, OH 45237 ; 5139485719
• MDR Report Key: 4095510
• MDR Text Key: 4832893
• Report Number: 1518293-2014-00102
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2014

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: HUT EXT DR FINAL A
• Device Catalogue Number: 404008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1