MAUDE Adverse Event Report: LIEBEL-FLARSHEIM ANGIOMAT ILLUMENA

Model Number 900001

Device Problem Defective Device (2588)

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

Event Date 12/10/2020

Event Type  malfunction  

Event Description

Thes incidents were reported by a facility in (b)(6) on (b)(6) 2020.Reporter states that they experienced error "2018", where powerhead pic is an invalid control state, and that a complex surgery had to be suspended.The incident did not occur during a procedure and there was no patient attached.The reporter also states that there was no injuries to patient or staff.

• Brand Name: ANGIOMAT ILLUMENA
• Type of Device: ANGIOMAT ILLUMENA
• 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: 11141647
• MDR Text Key: 227074325
• Report Number: 1518293-2021-00001
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K963071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900001
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1