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

Model Number 404007

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2018

Event Type  malfunction  

Event Description

This incident was reported on (b)(6) 2018 as a device malfunction resulting in no images when stepping on fluoro foot pedal.The reporter stated that an error image was not taken, and that release foot pedal sedecal screen was powered off.The event did occur during a procedure and the procedure was not completed and had to be rescheduled.Reporter stated that the sedecal console is shutting down during the attempted exposures, and phone call receiver requested that reporter attempt to take an exposure and the message center showed check collimator.Phone call receiver had reporter turn pbl override, which resulted in successful exposure, then turned back system returned to normal operation.Following this, the reporter called back on (b)(6) 2018 and stated that the facility has not had any issues from the last call until the day of the follow-up call, and stated that the sedecal touch screen, the older one, turned itself off again.The reporter was told that the fix would be a sedecal console upgrade.

• Brand Name: HUT EXT DR FINAL ASSY-REVERSE
• Type of Device: HUT EXT DR FINAL ASSY-REVERSE
• 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: 8240669
• MDR Text Key: 133190443
• Report Number: 1518293-2018-00046
• 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: distributor,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/11/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 404007
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/11/2019
• Date Device Manufactured: 08/31/2012
• 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