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

Model Number HUT EXT DR FINAL ASSY-STANDARD

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

Technical service troubleshot with customer their reported a table motion problem and determined that one of the hydraulic pumps had failed.Customer ordered replacement p/n 402066 and after speaking with tech support were able to repair the system themselves, and returned the unit to service.

Event Description

Customer reports all table motions failed during an unknown patient procedure.Staff was able to complete the procedure without incident.No reported injury.

• Brand Name: HUT EXT DR FINAL ASSY-STANDARD
• Type of Device: HUT EXT DR FINAL ASSY-STANDARD
• Manufacturer (Section D): LIEBEL FLARSHEIM; 2111 east galbraith road; cincinnati OH 45237
• Manufacturer Contact: david benson ; 2111 east galbraith road; cincinnati, OH 45237 ; 5139485719
• MDR Report Key: 5100444
• MDR Text Key: 26854513
• Report Number: 1518293-2015-00096
• 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 faci
• Reporter Occupation: Radiologic Technologist
• Report Date: 09/10/2015

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 ASSY-STANDARD
• Device Catalogue Number: 404008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2007
• 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