MAUDE Adverse Event Report: LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE; IXR

Model Number 404007

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2015

Event Type  malfunction  

Event Description

Customer reports via phone that during a urology stent placement procedure, on a male patient (age unknown), the system table movements failed.Staff manually moved the patient around on the table for physician to obtain proper images.Procedure was completed, and customer reports the patient is fine.No reported injury.

Manufacturer Narrative

Pending investigation.Upon receipt of investigation, a medwatch 3500a supplemental report will be submitted.

Manufacturer Narrative

Tech service spoke with customer who reported no table movement and discussed with the caller some troubleshooting steps.Biomed called back saying they had replaced the table's cpu board and were getting a 'check sum error'.Tech service explained this was because the current configuration was blank and explained to biomed how he could reconfigure their parameters, or he could have a fse come on site to assist.Biomed said he would call as needed.On a follow up phone call, the customer reported that the system had been repaired.They did not have any other details about the repair, but the system was fully functional.Device not returned to manufacturer.

• Brand Name: HUT EXT DR FINAL ASSY-REVERSE
• Type of Device: IXR
• 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: 4763691
• MDR Text Key: 15842618
• Report Number: 1518293-2015-00033
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/19/2015

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: 404007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 05/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2011
• 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