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

Model Number 404007

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

Quote was sent to facility for the console upgrade and other parts that may require replacing to troubleshoot issue.Facility will call in and request a new ticket for further service.

Event Description

Incident reported by facility on 30 june 2020 for an event that occurred on (b)(6) 2020.Facility stated the generator console is shutting down on its own.May be related to either overheating or cabling, or atp console board.Facility would like an inspection done on the system prior to replacing parts.The event occurred with no patient involvement.

• 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
• Manufacturer Contact: fred reckelhoff ; 2111 e. galbraith rd; oh
• MDR Report Key: 10460433
• MDR Text Key: 219186281
• Report Number: 1518293-2020-00017
• 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,health profession
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/30/2020

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: 06/30/2020
• Initial Date FDA Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1