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

Catalog Number SWU-2009

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Burn, Thermal (2530)

Event Date 12/14/2016

Event Type  Injury  

Manufacturer Narrative

Patient is a child of unknown age.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.

Event Description

It was reported that a patient (child) experienced "some burn' while a level 1® snuggle warm® blankets convective warming system was in use.It was indicated that the blanket overheated , burned the patient, and was attributed to a wet liquid."this wet liquid on the blanket, could have been the baby's urine.".

• Brand Name: LEVEL 1® SNUGGLE WARM® BLANKETS CONVECTIVE WARMING SYSTEM
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, bc 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6247676
• MDR Text Key: 64684070
• Report Number: 3012307300-2017-00038
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K141686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Catalogue Number: SWU-2009
• Device Lot Number: 3253076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2016
• 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): Other