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

Model Number SWU-2113

Device Problems Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 03/03/2017

Event Type  Injury  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the devices 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 the patient sustained a skin burn on the lower limbs after a level 1® snuggle warm® convective warming blanket was in use.The initial reporter noted that the device was set to warm to 44 degrees celsius.The blanket was in use for 90 minutes during a cardiac procedure.

• Brand Name: LEVEL 1® SNUGGLE WARM® CONVECTIVE WARMING BLANKET
• 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, 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 6526701
• MDR Text Key: 73848110
• Report Number: 3012307300-2017-00919
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 10610586043475
• UDI-Public: 10610586043475
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SWU-2113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other