MAUDE Adverse Event Report: ST PAUL LEVEL 1 EQUATOR CONVECTIVE WARMING DEVICE; SYSTEM, THERMAL REGULATING

Model Number 5000

Device Problems Device Emits Odor (1425); Fumes or Vapors (2529)

Patient Problem No Patient Involvement (2645)

Event Date 05/14/2020

Event Type  malfunction  

Manufacturer Narrative

One equator convective warming device was returned for analysis.Wear was found to the top and bottom of the enclosures upon visual inspection.The membrane switch, control board, mains board, and distribution cable were all noted to be outdated.The test hose was attached, the line cord was plugged in, the on button was pushed and high was selected on the keyboard; confirming complaint.Based on the evidence, the root cause is found to be due to a design issue as the impeller was observed to be grinding on the inside of the plenum.

Event Description

Information was received indicating that a burning smell was coming from inside a smiths medical level 1 equator convective warming device during testing.There were no reported adverse effects or patient involvement.

• Brand Name: LEVEL 1 EQUATOR CONVECTIVE WARMING DEVICE
• Type of Device: SYSTEM, THERMAL REGULATING
• 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: 10159295
• MDR Text Key: 195294239
• Report Number: 3012307300-2020-05982
• Device Sequence Number: 1
• Product Code: DWJ
• 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: 06/16/2020

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: 5000
• Device Catalogue Number: CON-EQ-5000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2005
• 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