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 Consequences Or Impact To Patient (2199)

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

Customer called service reporting that with patient on table they could not get fluoro to initiate.After removing patient, service troubleshot with customer; started a new test study, and power cycled the generator; but was unable to resolve issue.The facilities biomed later reported that they were able to reboot the `complete system' after getting off the phone with service, and the system came up and has been fully functional.

Event Description

During an unknown patient procedure, the system fluoro failed.Staff moved the patient and completed 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: 5437369
• MDR Text Key: 38787190
• Report Number: 1518293-2016-00010
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/02/2016

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: 02/02/2016
• Initial Date FDA Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2008
• 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