MAUDE Adverse Event Report: ST PAUL LEVEL ONE; FLUID WARMER

Model Number 230V GERMAN HOTLINE 2

Device Problems Electrical /Electronic Property Problem (1198); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation completed on a smiths medical fluid warming|level 1 hotline low flow systems - hl-290, the complaint of after a few minutes in use, the device suddenly started to smoke near the plug associated with a burnt unpleasant smell was confirmed.The physical aspect of the device revealed upon visual inspection, burn marks around cord along with photos.Also noted wear and tears around the enclosure.When duplicating the event, complaint was confirmed.Unable to confirm cause of event, however the power cord it is not an original power cord.And the last service for this device it was performed on may 2018, on our site.Please see the attached documents from the previous service.Action was taken to replace the emi filter and change power cord.Additional maintenance was completed as chassis was bent and temperature needed recalibration.Device then passed all functional testing.

Event Description

Reported a smiths medical fluid warming|level 1 hotline low flow systems - hl-290 had a burnt smell when powering on the device along with smoke.Photos were attached to reveal the damage to cord.It was reported no patient injury occurred.

• Brand Name: LEVEL ONE
• Type of Device: FLUID WARMER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11117839
• MDR Text Key: 225109592
• Report Number: 3012307300-2021-00068
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 230V GERMAN HOTLINE 2
• Device Catalogue Number: HL-290-GE-230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1