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

Model Number HUT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2015

Event Type  malfunction  

Event Description

Customer stated the fluoro failed during an unknown procedure.They were unable to reboot the system, so staff moved the patient and completed the procedure with a c-arm.No reported injury.No additional details are known.

Manufacturer Narrative

Field service engineer (fse) returned a call from a customer reporting they were unable to get x-ray exposure, fluoro or digital.Fse reported that the customer rebooted the infimed computer, table and generator.During this reboot the infimed computer powered up with a blue frozen screen.Fse had customer press and hold the power button on the infimed computer and reboot it, the infimed powered up normal.Customer opened a patient file and tested x-rays with no other problems; but wanted a fse visit to check system.Customer then called service again next day and said they believed the problem to be due to operator error as the table was used yesterday all day and again today with no problems, and customer wanted service to close the service ticket.

• Brand Name: HUT
• 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: 4649951
• MDR Text Key: 5614614
• Report Number: 1518293-2015-00019
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2015

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
• Device Catalogue Number: 404008
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2010
• 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