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

Model Number 414007

Device Problems False Alarm (1013); Appropriate Term/Code Not Available (3191)

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

Event Date 06/19/2018

Event Type  malfunction  

Event Description

Customer reports getting an error message: preparing to expose, but does not expose and also the error message stating tube warm up required.The operator states that a patient file is open.The system will not produce a digital rad, or fluoro.No interlocks seen at the sedecal or at the table.Patient was removed from the table to be moved to another room.

• 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 road; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e galbraith road; cincinnati, OH 45237
• MDR Report Key: 7699464
• MDR Text Key: 114713744
• Report Number: 1518293-2018-00024
• 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: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 414007
• Date Manufacturer Received: 06/14/2018
• Date Device Manufactured: 10/31/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1