MAUDE Adverse Event Report: ST PAUL LEVEL 1; SYSTEM, THERMAL REGULATING

Model Number SWU-2010

Device Problem Temperature Problem (3022)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 06/01/2018

Event Type  Injury  

Event Description

Information was received indicating that during use of a smiths medical level 1 snuggle warm blankets convective warming system the patient was noted to be burned.It was reported that the burns were located on the body near where the hose's connection port was and that "medical treatment" was performed.There were no further reported adverse effects.

• Brand Name: LEVEL 1
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 7652836
• MDR Text Key: 242890221
• Report Number: 3012307300-2018-02522
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 10610586043390
• UDI-Public: 10610586043390
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: SWU-2010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1