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

Model Number 404007

Device Problems Erratic or Intermittent Display (1182); Self-Activation or Keying (1557); Communication or Transmission Problem (2896); Optical Problem (3001); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2020

Event Type  malfunction  

Event Description

This incident was reported by a facility in (b)(6) on (b)(6) 2020.Incident: the reporter states that while flouring with footswitch, both monitors are glitching and the infirmed is continuously taking images even after releasing footswitch, but the images are all blank.The reporter also states that since the images are blank, it is not actually taking images, and when they try to view an image, it stays for about 10 seconds and then is replaced with a blank image continuously.He stated that he has rebooted the generator at this point to no avail.When he attempted to exit the application, the system would not respond, and had to make multiple attempts to exit.Reporter also stated later that he was getting a camera communication failure on the infirmed.Reporter states that the incident occurred during a procedure and that there was a patient attached to the device during the incident, but there was no injuries to patient or staff.

• 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 rd; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e. galbraith rd; cincinnati, OH 45237
• MDR Report Key: 10787228
• MDR Text Key: 225122705
• Report Number: 1518293-2020-00030
• 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,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1