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

Model Number HUT EXT DR FINAL ASSY-STANDARD

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

Tech service spoke with operator who said that the collimator did not have power and was completely black.The sedecal console was up and displaying the normal technique, but was displaying a message "check collimator" in the error center.The operator had power cycled the generator already, which would power cycle the collimator power as it takes power from the generator.Since this didn't correct the issue, tech service told operator that there was either a blown fuse / power issue from the generator or the collimator had failed and suggested that they have their biomed check this.Operator said that they would call back as needed.On (b)(6) 2015 product monitoring followed up with customer who reported that there service provider, phillips service group came out and repaired their system last night, but she did not know what they repaired.The system was now fully functional.

Event Description

Customer reports during a patient procedure the system fluoro failed with an error stating the collimator does not have power and is completely black.They power cycled the generator, which would power cycle the collimator power but the system still would not fluoro.Staff moved the patient to another room to complete the procedure with a c-arm.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: 5247344
• MDR Text Key: 32212953
• Report Number: 1518293-2015-00121
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/23/2015

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-STANDARD
• Device Catalogue Number: 404008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2009
• 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