MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE; SYSTEM, THERMAL REGULATING

Model Number	5000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Information was received indicating that a smiths medical level 1® equator® convective warming device was reported to have burned a patient's legs, leaving marks.The burns are noted to the patient's ankles and are treated daily.No further adverse effects were reported.
Additional Manufacturer Narrative
One used level 1® equator® convective warming device was received for investigation.The device was noted to be in good condition with the exception of the hose, which appeared to have damage to the hose helix due to improper storage or shipping.In a number of places, the hose helix was irregular in shape, but no tears were found in the hose material.The serial number of the hose matched the serial number of the device.No power cord was returned with the device.The filter was dirty.The device was powered on and passed occlusion testing.Temperature testing was performed and all temperature settings were found to be within tolerance.No failure modes were noted.Device operated as intended.

• Brand Name: LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7101785
• Report Number: 3012307300-2017-02526
• Device Sequence Number: 1934257
• Product Code: DWJ
• UDI-Device Identifier: 50695085000653
• UDI-Public: 50695085000653
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K011907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,user facilit
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 5000
• Device Catalogue Number: EQ-5000-ES-230V
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 12/08/2017
• Supplement Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability