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

Model Number 404008

Device Problem Radiation Overexposure (3017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2018

Event Type  malfunction  

Event Description

This incident was reported on (b)(6) 2018 as fluoro exceeding max exposure through lead.The technician stated that the event occurred during a procedure, which was completed, and there was no injury to patient or staff.The reporter stated that the fluoro exceeded limit of 10 rad per minute.

• Brand Name: HUT EXT DR FINAL ASSY-STANDARD
• Type of Device: HUT EXT DR FINAL ASSY-STANDARD
• 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: 8071373
• MDR Text Key: 127349660
• Report Number: 1518293-2018-00043
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 404008
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2018
• Date Device Manufactured: 12/31/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1