MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY,RE,FPD

Model Number 414007

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2018

Event Type  malfunction  

Event Description

Selected detector is not able to acquire images, stuck in the initializing phase.Message selected detector unable to acquire at this time, all question marks by the detector status, a red triangle where detector status is.Occurred after set up patient on table did not complete procedure.System was stating where the temperature is showing initializing but never went past that.The customer states that the system functioned as intended during their set up of the device.Patient file opened, warm up, test images.The patient was on the table for approximately 1 hour after the test images were taken then they attempted to perform fluoro without success.The system displayed initializing next to the detector status, this did not change.No exposure could be made from the system.Customer called into tech support.I had the customer shutdown the nexus, sedecal, unplug detector power supply, cycle the thales.Once this was complete the system returned to normal operation.It is unknown at this time why this has occurred.Fse required to further investigate and grab logs from nexus.

• Brand Name: HUT EXT DR FINAL ASSY,RE,FPD
• Type of Device: HUT EXT DR FINAL ASSY,RE,FPD
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e. galbraith rd; cincinnati, OH 45237
• MDR Report Key: 7292920
• MDR Text Key: 101122983
• Report Number: 1518293-2018-00003
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 01/25/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: 414007
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/23/2018
• Date Device Manufactured: 08/31/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1