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

Model Number 404007

Device Problem No Display/Image (1183)

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

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary: field service engineer (fse) traveled to fayetteville and assessed the video problem.One of the inputs to the hall effects box was wrong.Fse connected the input correctly and made the correct selections on the video output box.They were able to see the whole screen when the camera was used and also capture pictures on the printer.Fse checked operation according to checklist qssrwi 4.1.Unit returned to service.

Event Description

This incident was reported by a facility in (b)(6) on (b)(6) 2021.The customer complains that the monitors on the hydravision urology table are going out.Reporter also states that the incident happened during a procedure and that the procedure was completed, with no harm 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: 11278684
• MDR Text Key: 264305351
• Report Number: 1518293-2021-00002
• 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: company representative,health
• Reporter Occupation: 505
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/08/2021

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
• Device Lot Number: CI1008H388
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1