MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC., SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEMS; SYSTEM, THERMAL REGULATING

Catalog Number ASKU

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

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

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.Device did not return.

Event Description

The event was reported by the (b)(6) hospital.The incident that occurred was on a (b)(6) patient who suffered first and second degree burns on lateral aspects of both upper thighs and both lower lateral arms during a neurosurgical procedure, while using a hf equator and a swu-2011 pediatric underbody blanket.The patient's temperature in the or was under 35 degrees c.The device was set at 40 and the patient's temperature rose to 37 degrees immediately.The device was kept consistently at 40 degrees setting throughout the 2.5 - 3 hour procedure.No alarms went off during the procedure.The burns were found on the patient after the patient was admitted into the picu.Dermatology was brought in to consult and an antibiotic ointment was used for the burn.The patient was brought back to the hospital and the burns had healed.Additionally, the hospital's clinical engineer confirmed, that nothing was found wrong with the equator and the pediatric underbody blanket was disposed of.

• Brand Name: SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEMS
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.,; 1265 grey fox rd; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 1265 grey fox rd; st. paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5731001
• MDR Text Key: 47585600
• Report Number: 2183502-2016-01200
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 2 YR