MAUDE Adverse Event Report: LEVEL 1; HOTLINE LOW FLOW SYSTEM

Catalog Number CON-HL-90

Device Problem Temperature Problem (3022)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received that device is not heating correctly.No adverse effects reported.

Manufacturer Narrative

Device evaluation- the device was returned for evaluation.The device was given functional testing; this verifies the device did not heat the fluid due to a fault with the heater.

• Brand Name: LEVEL 1
• Type of Device: HOTLINE LOW FLOW SYSTEM
• MDR Report Key: 11279867
• MDR Text Key: 230298828
• Report Number: 3012307300-2021-00847
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1