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

Model Number HUT EXT DR FINAL ASSY-REVERSE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

Tech service troubleshot with the biomed, who said that intermittently they were losing fluoro.Biomed said that he had inspected the ht cable candle sticks at both the tube and ht transformer ends and since everything was plugged back in the system had not failed once.On a follow up call, the customer reported the system was fully functional.There were no parts replaced and that the biomed was able to reseat and grease the high tension cables on the high voltage circuit and this had resolved the problem.

Event Description

Customer reports the fluoro failed during an unknown procedure.Staff moved the patient to another room and completed the case without incident.No reported injury.

• Brand Name: HUT EXT DR FINAL ASSY-REVERSE
• Type of Device: HUT EXT DR FINAL ASSY-REVERSE
• 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: 5130145
• MDR Text Key: 27869041
• Report Number: 1518293-2015-00101
• 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
• Report Date: 09/22/2015

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-REVERSE
• Device Catalogue Number: 404007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2006
• 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