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

Catalog Number HL-90-INT-230

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Occupation: medical technician.

Event Description

Information was received indicating that a smiths medical level 1 hotline low flow system had a micro switch problem (disposable l-70 was not recognized).There was no reported adverse event.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEMS
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11094808
• MDR Text Key: 224387506
• Report Number: 3012307300-2020-12846
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2020

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 Catalogue Number: HL-90-INT-230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• 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