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

Model Number 414008

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/24/2017

Event Type  malfunction  

Event Description

Failed in the middle of a procedure.Room (b)(6).The customer stated they were in the middle of a case where the application froze and will not respond, when attempted, the doctor cannot fluoro/expose.

• Brand Name: HUT EXT DR FINAL ASSY,ST,FPD
• Type of Device: HUT EXT DR FINAL ASSY,ST,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: 6417202
• MDR Text Key: 70546567
• Report Number: 1518293-2017-00009
• 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: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 414008
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2017
• Date Device Manufactured: 03/31/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1