MAUDE Adverse Event Report: LIEBEL-FLARSHEIM HUT EXT DR FINAL ASSY,ST,FPD

Model Number 414008

Device Problem Output Problem (3005)

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

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

10/19/20: unable to duplicate the reported.Rebooted the entire system, (nexus, generator, gim), verified operation according to service checklist ((b)(4)).The system is fully functional.

Event Description

This incident was reported by a facility in (b)(6) on (b)(6) 2020.The customer states that the fluoro stopped during procedure.The tech had to restart the infimed several times in order to complete the procedure.The reporter also states that the patient was attached to the device during the incident but there was no harm to patient or staff, and that the procedure was completed.

• Brand Name: HUT EXT DR FINAL ASSY,ST,FPD
• Type of Device: HUT EXT DR FINAL ASSY,ST,FPD
• 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: 10828714
• MDR Text Key: 247662307
• Report Number: 1518293-2020-00033
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121838
• 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
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/15/2020

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: 414008
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1