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

Model Number 414007

Device Problems No Device Output (1435); Computer Operating System Problem (2898)

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

Event Date 05/17/2017

Event Type  malfunction  

Event Description

Not imaging at all.Tech unable to produce images, fluoro or rad.Multiple system reboots and gim resets but still unable to produce image.Powered system off and left until service arrives, when system started it works.Follow up information: "after the system failed there was no fluoro or rad.There was fluoro and rad when they started the case".

• 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: 6640568
• MDR Text Key: 77728407
• Report Number: 1518293-2017-00018
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/14/2017

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
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 06/14/2017
• Date Device Manufactured: 02/28/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1