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

Model Number 404007

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2015

Event Type  malfunction  

Event Description

Customer reports via phone that during an urology stent placement, the system fluoro failed.Physician completed the procedure using endoscopy.Customer provided no further procedure or patient information, other than to say the patient is fine.No reported injury.

Manufacturer Narrative

Field service engineer (fse) went on site to investigate a complaint of a message on the table imaging monitor of "no camera detected" and was unable to fluoro.Customer said the next morning he (customer) tested the system and it was operating properly.Fse was unable to duplicate the no camera detected message.Fse checked camera connections at the camera and infimed, tried heating up the camera using fluoro to see if there was a heat problem, but never received the message.Fse then moved the table while using fluoro to see if the no camera detected message appears and it did not appear.Fse after testing the table, verified proper operation according to service checklist and returned unit to service.No problem found.

• 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: 4727188
• MDR Text Key: 5746186
• Report Number: 1518293-2015-00028
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/02/2015

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2009
• 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