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

Model Number 5000

Device Problem Temperature Problem (3022)

Patient Problems Erythema (1840); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 07/01/2019

Event Type  Injury  

Event Description

Information was received indicating that upon removal of a smiths medical level 1® equator® convective warming blower erythema was noted to the patient's arm, forearm, chest and abdomen.The right forearm was reported to show the beginning of phlycten.The clinician stated that the patient was well positioned on the blanket without any external constraint.The warmer was reported to set to 44 degrees celsius but the display had read 37 degrees celsius.Subsequently, biafine was prescribed for dressings.There were no further reported adverse effects.

Manufacturer Narrative

One convective warming device was returned for evaluation.Visual inspection of the device found it to be have wear and tear damage on top enclosures, as well as an outdated otor mount plate and impeller.Device underwent functional testing and ran for several hours.No temperature spike was noted, was stabalized at 44 degrees according to the digital thermometer.The reported customer allegation was unable to be confirmed.This investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.

• 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: 8843571
• MDR Text Key: 152711424
• Report Number: 3012307300-2019-03892
• 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
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5000
• Device Catalogue Number: EQ-5000-FR-230V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention