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

Model Number 5000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Type  Injury  

Manufacturer Narrative

Report source: (b)(6).

Event Description

Information was received indicating that a smiths medical level 1® equator® convective warming device burned a patient.There were no reported further adverse effects.

Manufacturer Narrative

Additional information was received indicating that second degree and third degree burns were noted to the patient's toes following use of a level 1® equator® convective warming device.The patient was reported to have been lying flat on his back during the procedure.Jelonet dressings and flammazine cream were used for the treatment of the burns.Prolonged sedation and immobilization with extended hospital stay was reported.There was no further reported adverse effects.

Manufacturer Narrative

Evaluation results: one level 1® equator® convective warming device was returned for investigation.The device was slightly dirty but in good condition.The hose (#sw5-hose-7) was damaged.The power cord (#6051008) was not the original one.When tested however the values were found to be acceptable.The device passed the initial self-test.The investigator then selected for different temperatures.The device initially worked as intended.The hose sensor cable was then manipulated to see if the product problem could be replicated.No issues were identified.The device passed all the functional tests.No fault was found with the device.

• Brand Name: LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 8688979
• MDR Text Key: 147659332
• Report Number: 3012307300-2019-03240
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2020

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?: Yes
• Device Operator: No Information
• Device Model Number: 5000
• Device Catalogue Number: EQ-5000-FR-230V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 06/12/2019; 01/21/2020
• Supplement Dates FDA Received: 07/10/2019; 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention