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

Model Number EQ-5000-UK-230V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 10/25/2018

Event Type  Injury  

Manufacturer Narrative

Report source: foreign, (b)(6).

Event Description

Information was received that during the use of a smiths medical level 1 equator convective warming system, the product was set to 40 degrees leading to the observation of the patient's skin to be warm, red and noted blisters.It was reported that the device was removed and cold compresses were applied to the patient's skin.It was also reported that "the patient is now requiring treatment under the plastics team." no further adverse patient effects were reported.

• Brand Name: LEVEL 1 EQUATOR CONVECTIVE WARMING SYSTEM
• Type of Device: SYSTEM, THERMAL REGULATING PRODUCT CODE: DWJ
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8419117
• MDR Text Key: 138755637
• Report Number: 3012307300-2019-01340
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQ-5000-UK-230V
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention