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

Model Number 404007

Device Problem Positioning Problem (3009)

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

Event Date 06/14/2018

Event Type  malfunction  

Event Description

Customer reports that device is in error stating monitor collision with table, tilts 20 degrees, and the table thinks the tube head is hitting the monitors but it is not. Table is tilted with feet in the air about 20 degrees. Upon follow-up call, customer stated that he was able to get the table down and tilted the head back up to level by using the collision override button. When this incident originally occured, the patient had to be taken off the table with the table tilted head down and higher than they wanted it. He did not have knowledge, however, if the case was completed. Upon follow-up call on (b)(6) 2018, customer stated that the table is tilted head down, 20 degrees, which is the max head down. When they try and tilt the head end back up, they get the message, monitor collision. Additionally, the table will down move down elevation; only up.

• 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: 7685203
• MDR Text Key: 114543772
• Report Number: 1518293-2018-00022
• 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

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 404007
• Was Device Available for Evaluation?: No Answer Provided

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/31/2008
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage