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

Catalog Number SWU-2001

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 level 1® snuggle warm® blanket.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.

• 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
• Manufacturer (Section G): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 8689351
• MDR Text Key: 147737355
• Report Number: 3012307300-2019-03212
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/23/2021
• Device Catalogue Number: SWU-2001
• Device Lot Number: 3635259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention