MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC LEVEL 1 HOTLINE LOW FLOW SYSTEM; WARMER, THERMAL, INFUSION FLUID

Model Number HL-390

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that the device exhibited a loud squealing noise.In addition, the tank cover was damaged.No patient injury or complications were reported in relation to this event.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEM
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 3350 granada avenue north; suite 100; oakdale, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 10030572
• MDR Text Key: 190058241
• Report Number: 3012307300-2020-03722
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2020

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: No Information
• Device Model Number: HL-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 05/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1