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

Model Number HUT

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2014

Event Type  malfunction  

Event Description

Customer reports they had a no fluoro event and a popping noise came from the generator during a patient procedure.Staff moved the patient to another room and completed the procedure with a c-arm.No reported injury.No other details are known.

Manufacturer Narrative

Mallinckrodt field service engineer (fse) went on site to investigate a popping noise in the cysto room during an x-ray.During fluoro shots, he could not duplicate complaint.As a precaution, the fse removed the high tension cables from x-ray tube and cleaned and regreased the high voltage candle sticks.Fse completed a preventative maintenance of the system with no popping or arcing sounds heard.System checklist was completed and returned to the customer for full service.

• Brand Name: HUT EXT DR FINAL ASSY-STANDARD
• Type of Device: HUT
• 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: 4140223
• MDR Text Key: 4927932
• Report Number: 1518293-2014-00125
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/19/2014

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
• Device Catalogue Number: 404008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2014
• Initial Date FDA Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2004
• 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