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

Model Number HL-90

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that there was a switch issue to a smiths medical level 1® hotline® low flow system.There were no reported adverse effects.

Manufacturer Narrative

One level 1 hotline low flow systems - hl-90 was returned for analysis.The device was in very good condition.Testing started with filling up the tank with water and turning on the power switch.The reported issue of a "switch issue" was confirmed and was due to a bad micro switch assembly.The micro switch was replaced and the device was re-caliberated.

• 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 n; minneapolis,, mn
• MDR Report Key: 9887345
• MDR Text Key: 185192158
• Report Number: 3012307300-2020-02161
• 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: 06/15/2020

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: No Information
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/27/2020
• Supplement Dates Manufacturer Received: 04/16/2020
• Supplement Dates FDA Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1