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

Model Number 404008

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/23/2017

Event Type  malfunction  

Event Description

Inspection report failed.Dark line/object appears in the images and the maximum fluoro output exceeds the regulatory limit and the collimation is inadequate and fails for normal mag 1 mag2.On (b)(6): inspection report failed.Dark line/object appears in the images and the maximum fluoro output exceeds the regulatory limit and the collimation is inadequate and fails for normal mag 1 mag2.Then on (b)(6) confirmation of the issue: fse diagnosis & work performed: check system according checklist #(b)(4) found maximum fluoroscopic at 11.3 r/min, adjusted to 9.7 for adult and pediatric at 4.2 and removed a piece of metal between table top and image intensifier witch is blocking the image and check collimator blades all normal.The problem was corrected (as explained above) and that the suspected root cause at this time would be : a miscalibration of the device upon servicing resulting in the maximum output of the system is set to 11.3 r/min while it should not exceed 10r per minute in fluoro.The setting works when the system is in the automatic mode.This may have resulted in the remote possibility of reaching this maximum output in case a very overweight person had undergone a procedure with this setting.To be noted that the device does not have high level fluoro.

• 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 rd; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e. galbraith rd; cincinnati, OH 45237
• MDR Report Key: 6911112
• MDR Text Key: 89719551
• Report Number: 1518293-2017-00027
• 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: health professional
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 404008
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2017
• Date Device Manufactured: 02/29/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1